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Clinical Trials – Active Studies

CLINICAL TRIALS – ACTIVE STUDIES

A summary of current clinical trials for Alport syndrome is listed below. For more information on a specific trial, visit clinicaltrials.gov. If you reach out to a trial sponsor or study site contact and do not receive a timely response, please email [email protected].

To learn about the different stages in the development of new treatments, visit this page.

To view questions and considerations related to clinical trial enrollment, view our educational resource.

 

View ASF’s Policy for Engaging with Industry (Rev. Jan. 2023)

Active Clinical Trials At A Glance

View the table below for an overview of active clinical trials. Scroll to the bottom of this page for an archival listing of past trials.

Table Key

UACR: urine albumin to creatinine ratio
UPCR: urine protein to creatinine ratio
eGFR: estimated glomerular filtration rate

You can click on the name of any study within the “Study Name” column to view its respective clinicaltrials.gov listing.

Study NameStudy LinkDrug NameLocationAgeUACR / UPCReGFRCurrently Enrolling Alport Patients?
AFFINITYhttps://clinicaltrials.gov/ct2/show/NCT04573920atrasentanU.S. / Int’l18+UPCR > 0.5 g/g≥ 30 mL/min/1.73 m2No
ALPESTRIA-1Coming SoonvonafexorU.S. / Int’l16-40Expected 2024
ELX-02https://clinicaltrials.gov/ct2/show/NCT05448755ELX-02U.K. 6 to 30UPCR ≥ 500 mg/g> 60 mL/min/1.73 m2No
EPPIKhttps://clinicaltrials.gov/ct2/show/NCT05003986sparsentanU.S. / Int’l1 to 18UPCR ≥ 1.5 g/g≥ 30 mL/min/1.73 m2No
FIONAhttps://clinicaltrials.gov/ct2/show/NCT05196035finerenoneU.S. / Int’l
6 months - 18 yrs
Varies by age≥30 ml/min/1.73 m2Yes
R3R01 - ASFFSGS - 201https://clinicaltrials.gov/ct2/show/NCT05267262R3-R01U.S. / Int’l18+UPCR ≥ 1.0 g/g≥ 45 mL/min/1.73 m2Yes

The AFFINITY Study

Conducted by Chinook, A Novartis Company

STATUS + LOCATIONS

As of May 2023, the Alport syndrome cohort of AFFINITY is complete and the study is not currently enrolling new patients.

STUDY UPDATE

August 3, 2023: Novartis today announced that it has completed its acquisition of Chinook Therapeutics, Inc., a Seattle, WA, based biopharmaceutical company focused on the discovery, development, and commercialization of precision medicines for kidney diseases, in a transaction valued at up to USD 3.5 billion.

CLICK HERE TO READ THE FULL AUGUST 3RD PRESS RELEASE

SUMMARY

As of May 2023, the Alport syndrome cohort of AFFINITY is complete and the study is not currently enrolling new patients.

The AFFINITY study is a phase 2 clinical trial testing an investigational medication called atrasentan. Atrasentan has potential to benefit in Alport Syndrome and other glomerular diseases by reducing the amount of protein in the urine and preserving kidney function.

  • The goal of the study is to evaluate the effect of atrasentan on proteinuria in patients with Alport Syndrome, IgA nephropathy, focal segmental glomerulosclerosis, and in patients with diabetic kidney disease who are taking an SGLT2 inhibitor.
  • Approximately 20 patients will be enrolled in each group, including 20 patients with Alport Syndrome (~80 patients total). Patients in this study will receive atrasentan as an oral tablet once a day for approximately 1 year.
  • To facilitate study participation, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered. Patients will be reimbursed for study-related expenses, such as travel, flight, or lodging costs.
  • Enrollment began in the United States, Australia, South Korea, Italy, Spain, and the United Kingdom in early 2021.

More information on this study can be found on clinicaltrials.gov. Inquiries can be sent by email to [email protected] or by phone at 1-888-669-6682.

ALPESTRIA-1

ALPESTRIA stands for Alport Syndrome Efficacy & Safety Trial-1

Conducted by ENYO Pharma

STATUS + LOCATIONS

Enrollment will begin in early 2024; locations in the U.S. and abroad (France, Germany, Spain) to be announced.

STUDY UPDATE

January 3, 2024: ENYO Pharma announced that it has received clearance of its Investigational New Drug application from the U.S. Food and Drug Administration to initiate a Phase 2 clinical study of Vonafexor, a highly selective FXR agonist, for the treatment of Alport syndrome.

VIEW THE FULL JANUARY 3, 2024 PRESS RELEASE

SUMMARY

  • The phase 2 study will evaluate the safety of Vonafexor in Alport syndrome and the benefit of three dose levels of Vonafexor on renal function and biomarkers.
  • The drug in this study aims to preserve kidney function and reverse kidney damage in patients with Alport syndrome.
  • The study aims at enrolling 20 patients in U.S. and EU (France, Germany and Spain).
  • This is not a placebo-controlled trial, meaning that all participants will receive Vonafexor as oral tablets once daily for 24 weeks and then stop the treatment for 12 weeks in the follow-up period.
  • Assessments are a mix of 5 site visits, 4 home visits and 4 phone calls, with urine and/or blood sampling.
  • ENYO Pharma has received Orphan Drug Designations for Vonafexor in Alport syndrome by both the FDA and the European Medicines Agency (EMA).
  • Eligibility information can be found in the “Active Clinical Trials at a Glance” table above.

 

Additional Resources:

Click here to view an educational flyer about ALPESTRIA-1.

A Study of ELX-02 in Patients With Alport Syndrome

Conducted by Eloxx Pharmaceuticals, Inc. 

STATUS + LOCATIONS

Currently Enrolling in the United Kingdom.

STUDY UPDATE

April 16, 2024: Eloxx Pharmaceuticals, Inc., a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today provided program updates for ELX-02 and ZKN-013, including Orphan Drug Designation (ODD) for ELX-02.

VIEW THE FULL APRIL 16, 2024 PRESS RELEASE

October 9, 2023: Eloxx Pharmaceuticals, Inc., a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today reported results from an assessment of patient biopsies by NIPOKA GmbH (Nipoka). They have developed a highly accurate method for the quantification of podocyte foot process morphology. These results confirm previously reported positive biopsy results from the proof-of-concept Phase 2 open-label clinical trial (NCT05448755) of ELX-02 for the treatment of Nonsense Mutation Alport syndrome patients.

VIEW THE FULL OCTOBER 9, 2023 PRESS RELEASE

September 7, 2023: Eloxx Pharmaceuticals provided an update on the continued advancement of ELX-02 for the treatment of Alport syndrome with nonsense mutations, including additional positive results from its Phase 2 clinical study evaluating ELX-02

VIEW THE FULL SEPTEMBER 7, 2023 PRESS RELEASE

SUMMARY

Eloxx, a pharmaceutical company, is testing a new treatment that they think might help certain people with Alport Syndrome. Alport syndrome is caused by changes (called mutations) in certain genes. Only a very small proportion of gene changes (called ‘nonsense mutations’ which account for approximately 3-5% that cause Alport syndrome) are potentially treatable by this new testing treatment (called ELX-02).

The main goal of this study (called EL-014) is to learn whether ELX-02 is safe in Alport patients and whether it improves kidney function and hearing. The study currently has trial sites in the UK. Patients who participate in RaDaR (the UK national registry of rare kidney diseases, which is open at 107 hospitals across the UK), have mild kidney damage and have had a genetic test showing that they have the relevant type of gene change (a nonsense mutation) may be eligible to take part in the study. If you are in the UK and want to find out more about RaDaR and genetic testing, please ask your kidney doctor. If you are not in RaDaR but would like to find out whether you are suitable for the Eloxx study, please telephone the study site below. Please note that the study team will need to know your genetic test result and latest kidney function reading (called eGFR) to be able to tell whether you might be eligible for this study.

Contact:

UK – Royal Free Hospital, London (adults)

Professor Daniel Gale: 020 7472 6491

Criteria for Alport syndrome patients appropriate for the Eloxx study include:

  • Are 6-30 years of age (inclusive)
  • Have a confirmed diagnosis of X-linked Alport syndrome with a nonsense mutation in COL4A5, or a diagnosis of autosomal recessive Alport syndrome with two nonsense mutations in either COL4A3 or COL4A4
  • Have over a certain value of kidney filtration rate (eGFR >60ml/min/1.73m2)
  • Have not received a kidney transplant
  • Live in the United Kingdom
  • Available for 60 days treatment with bi-weekly visits, followed by 3 months with monthly visits

EPPIK Clinical Study for Children with Rare Kidney Diseases

EPPIK stands for Evaluating Problematic Proteinuria in Kids

Conducted by Travere Therapuetics 

STATUS + LOCATIONS

STUDY UPDATE

Study updates will be added to ASF’s website as they become available.

SUMMARY

Travere’s investigational approach is to lower proteinuria levels with sparsentan and slow the loss of kidney function in children with:

– Focal segmental glomerulosclerosis (FSGS)
– Minimal change disease (MCD)
– IgA nephropathy (IgAN), also known as Berger’s disease
– IgA vasculitis (IgAV), also known as Henoch-Schönlein purpura
– Alport syndrome (AS)

Travere Therapeutics is now enrolling children with rare kidney diseases in the EPPIK clinical study, including Alport syndrome patients ages 2-7.

Click here to view a Frequently Asked Questions document about the EPPIK Clinical Study.

The EPPIK Study is a 108-week pediatric study that is evaluating sparsentan in FSGS, MCD, IgAN, IgAV and Alport syndrome. This study is an EU regulatory requirement to support approval submissions for IgAN and FSGS. It is not designed to ultimately support an approval in MCD, IgAV or Alport syndrome. The EPPIK study will evaluate the investigational drug, sparsentan, for the treatment of selected rare kidney diseases. Kidneys are important organs that filter waste products from blood into the urine. The rare kidney diseases included in the EPPIK study are characterized by gradual loss of kidney function and increased protein in the urine (proteinuria). Proteinuria is seen as a marker of kidney function and lowering its level is associated with slowing down the loss of kidney function and better kidney outcomes.

The FIONA Study

(A 6-month Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and PK/PD of an age-and Body Weight-adjusted Oral Finerenone Regimen, in Addition to an ACE Inhibitor or Angiotensin Receptor Blocker, for the Treatment of Children, 6 Months to <18 Years of Age, With Chronic Kidney Disease and Proteinuria)

Conducted by Bayer AG. 

STATUS + LOCATIONS

Currently enrolling patients from 12 to < 18 years of age.

Click here for a list of current study sites.

STUDY UPDATE

SUMMARY

• The FIONA study is a phase 3 placebo-controlled clinical trial testing an investigational medication called finerenone.
• The main goal of the study is to evaluate the effect of the investigational medication finerenone on proteinuria in patients with CKD who have proteinuria despite taking either an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB).
• Secondary goals include learning whether the investigational product finerenone is safe and well tolerated, how it moves into, through and out of the body, and how participants like the age-appropriate formulation.
• Approximately 219 patients < 18 years of age with CKD stages 1, 2 or 3 (eGFR ≥ 30 ml/min/1.73 m2) and a UPCR ≥ 0.5 g/g if in CKD stages 2 and 3 (eGFR 30 – 89 ml/min/1.73 m2) or ≥ 1 g/g if in CKD stage 1 (eGFR ≥ 90 ml/min/1.73 m2) will be randomized.
• Patients in this study will receive the investigational product finerenone or placebo once daily by mouth for approximately 6 months.
• To facilitate study participation, where possible and allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.
• Patients will be reimbursed for study-related expenses such as travel or lodging costs if allowed by local regulations.
• Enrollment is ongoing in many European countries, Turkey, Israel, South Korea and Australia. First study sites in Canada and the USA are open for enrolment.
• More information on this study can be found on ClinicalTrials.gov.

The R3R01 – ASFSGS Study

Conducted by River 3 Renal Corp.

 

 

STATUS + LOCATIONS

Currently Enrolling.

Click here to view a list of active study sites and contact information as of January 31, 2024.

UNITED STATES:

Academic Medical Research Institute
Los Angeles, California
Contact: [email protected]

University of Miami Leonard M. Miller School of Medicine
Miami, Florida
Contact: [email protected]

Emory University
Atlanta, Georgia
Contact: [email protected]

Tufts Medical Center
Boston, Massachusetts
Contact: [email protected]

University of Michigan Medical School
Ann Arbor, Michigan
Contact: [email protected]

University of Minnesota Children’s Hospital
Minneapolis, Minnesota
Contact: [email protected]

North Carolina Nephrology, P.A.
Cary, North Carolina
Contact: [email protected]

Cleveland Clinic
Cleveland, Ohio
Contact: [email protected]

The Ohio State University
Columbus, Ohio
Contact: [email protected]

Dallas Nephrology Associates (Dallas Landry Office)
Dallas, Texas
Contact: [email protected]

Prolato Clinical Research Center
Houston, Texas
Contact: [email protected]

INTERNATIONAL:

CHU Sart-Tilman
B35 Liege, B-4000
Belgium
Contact: [email protected]

Cliniques Universitaires Saint Luc
Hippokrateslaan 10 Bruxelles, 1200
Belgium
Contact: [email protected]

CHU Grenoble Hospital Nord Michallon
Avenue Maquis du Gresivaudan Grenoble, 38043
France
Contact: [email protected]

CHU Paris – Hospital Necker-Enfants Malades
149 rue de Sevres Paris Cedex 15, 75015
France
Contact: [email protected]

Charite Universitaetsmedizin Berlin – Campus Benjamin Franklin
Hindenburgdamm 30, 12203 Berlin
Germany
Contact: [email protected]

Clinic of Nephrology & Rheumatology Gottingen
Robert-Koch-Straße 40 37075 Göttingen
Germany
Contact: [email protected]

Amsterdam UMC
Meibergdreef 9 Amsterdam, 1105AZ
Netherlands
Contact: [email protected]

Radboud UMC Niimegen Nephrology
Geert Grooteplein Zuid 8 Nijmegen, 6525 GA
Netherlands
Contact: [email protected]

Nottingham University
Hucknall Road Nottingham, NG5 1PB
United Kingdom
Contact: [email protected]

Royal Manchester Children’s Hospital
Oxford Road Campus Manchester, M13 9WL
United Kingdom
Contact: [email protected]

University Hospitals of Leicester NHS Trust
Leicester General Hospital Leicester, England, LE5 4PW
United Kingdom
Contact: [email protected]

STUDY UPDATE

River 3 Renal Corp. is a drug development company focused on the development and commercialization of treatments for chronic kidney diseases. They have initiated a phase 2 clinical trial to evaluate the efficacy and safety of R3R01, a molecule intended to reduce the accumulation of toxic lipids in podocytes and thereby help to improve kidney function. Study sites will be opened in the U.S., U.K., and Europe. A current site listing can be found above. As additional sites are opened, the list will be updated.

SUMMARY

R3R01-ASFSGS-201 is a phase 2 clinical trial testing an investigational medication called R3R01. R3R01 has the potential to benefit patients with Alport syndrome and other glomerular diseases by preserving or improving kidney function and reducing the amount of protein in the urine.

  • The goal of the study is to evaluate the effect of R3R01 on proteinuria in patients with Alport syndrome and focal segmental glomerular sclerosis (FSGS).
  • The trial is open to Alport syndrome patients 18 years and older, including males and females with X-linked Alport syndrome, and males and females with Autosomal Recessive Alport syndrome.
  • Approximately 20 patients with Alport syndrome and 30 patients with FSGS (~50 patients total) will be enrolled. Patients with Alport syndrome should have a confirmed diagnosis of Alport syndrome by genetic testing and /or kidney biopsy, a UPCR >= 1.0 g/g and eGFR >= 45 mL/min. Patients with FSGS should have steroid-resistance, a UPCR between 3.5 g/g and 12.0 g/g and an eGFR >= 45 mL/min.
  • All patients will receive R3R01 as oral tablets twice a day for approximately 3 months.
  • This is an open label study, so all participating patients will receive R3R01.
  • Patients will remain on their current dose of angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE/ARB) therapy during the trial, unless they had previously discontinued use for intolerability or lack of efficacy.
  • Patients will be reimbursed for study-related expenses, as approved by the applicable Institutional Review Board or Ethics Committee.

More information on this study can be found on clinicaltrials.gov (NCT05267262). To inquire about screening for the study, contact: [email protected] or [email protected].

See below for an archive of past clinical trials for Alport syndrome.

Click Here for a Summary of Past Clinical Trials

An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)

Conducted by Reata Pharmaceuticals

STATUS

No longer enrolling Alport syndrome patients.

STUDY UPDATE

On May 10, 2023, Reata Pharmaceuticals provided a written statement to ASF regarding the termination of the EAGLE Study. Questions can be directed to Reata via their call center at (800) 314-3934.

On December 20, 2022, Reata Pharmaceuticals provided a written statement to ASF regarding the EAGLE Study

On January 21, 2022, Reata Pharmaceuticals provided a written statement to ASF and the larger community of Alport syndrome patients and families regarding the EAGLE Study

SUMMARY

UPDATE: On May 10, 2023, Reata Pharmaceuticals provided a written statement to ASF regarding the termination of the EAGLE Study. Questions can be directed to Reata via their call center at (800) 314-3934.

EAGLE was an extended access study assessing the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl.

Freedom-1 Phase 3 Study

Conducted by Talaris Therapeutics

STATUS + LOCATIONS

February 16, 2023 Update: Talaris Therapeutics, Inc. has decided to discontinue its FREEDOM-1 and FREEDOM-2 clinical trials evaluating FCR001’s ability to induce durable tolerance in living donor kidney transplant recipients. Read the press release.

STUDY UPDATE

February 16, 2023: Talaris Therapeutics, Inc. has decided to discontinue its FREEDOM-1 and FREEDOM-2 clinical trials evaluating FCR001’s ability to induce durable tolerance in living donor kidney transplant recipients. This decision was primarily attributable to the pace of enrollment and the associated timeline to critical milestones.

VIEW THE FULL FEBRUARY 16, 2023 PRESS RELEASE

November 10, 2022: Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today reported financial results for the three- and nine-month periods ended September 30, 2022 and provided an update on its business.

VIEW THE FULL NOVEMBER 10, 2022 PRESS RELEASE

June 22, 2022: You can watch a closed captioned, educational webinar about the FREEDOM-1 Study and FREEDOM-2 Study at this link.

SUMMARY

The FREEDOM-1 Study is a clinical research study now enrolling adults who plan to receive a kidney transplant from a living donor. The purpose of this study is to learn more about whether a novel cell therapy called FCR001 can prevent the rejection of living donor kidney transplants without the need for lifelong anti-rejection drugs.

Although anti-rejection medicines are very effective at preventing rejection of kidneys, particularly in the first several years following the transplant, multiple side effects and tolerability issues can affect recipients’ ability or willingness to take these medicines, ultimately adversely affecting long-term outcomes for donated kidneys and recipients.

FREEDOM-1 is a Phase 3 clinical trial that will compare the efficacy and safety of FCR001 treatment to standard anti-rejection treatment. This study is now enrolling at sites around the U.S. Find out where the study is being offered here. To learn more about the study and determine if you are eligible to participate, click here.

You can watch a closed captioned, educational webinar about the FREEDOM-1 Study and FREEDOM-2 Study at this link.

HERA Phase 2 Study (Continued)

Conducted by Sanofi-Genzyme

STATUS

JULY 13, 2022 UPDATE: Alport Syndrome Foundation has issued a press release regarding the status of the HERA Study.

SUMMARY

As of November 2019, the HERA clinical trial has been officially re-initiated.

The HERA study was re-initiated after the study was put on hold in 2018 by Regulus Therapeutics for non-safety and non-regulatory reasons. Sanofi has taken over the development of SAR339375 and re-initiated the clinical study after the protocol design was re-assessed and optimized. Sanofi is seeking Alport patients who meet the inclusion criteria in the US, Europe, China and Australia.

The effectiveness and safety of lademirsen (SAR339375), an anti-miR21 compound, is being investigated in a two years study consisting of different periods. In the double-blind period (first year), Sanofi is comparing the investigational drug with a placebo (which looks like the investigational drug, but contains no active medicine). The second year is an open-label period where every patient receives the active investigational medicine. After two years of treatment, there is a 10-week follow-up period.

Patients will have weekly visits, either at the study center or at home. At a minimum, patients will need to visit the study center every 3 months. There will be no cost to the patient while participating in this trial. Travel and lodging will be reimbursed. The investigational drug (and placebo) are provided as an injection under the skin using a small gauge needle. Periodic tests and assessments are to be done, such as blood and urine tests, hearing assessments, ECG, genetic sequencing. Biopsies are not required during the study.

The study is looking for male and female patients who:
· Are 18-55 years of age (inclusive)
· Have a confirmed diagnosis of Alport syndrome
· Have a certain value of kidney filtration rate (eGFR >35 ml/min/1.73m2 and <90 ml/min/1.73m2)
· Have not received a kidney transplant
· Are currently not on dialysis
· Are less than 110kg (242 pounds)
· Do not have diabetes mellitus

More information on this study can be found on the HERA Clinical Trial website and the ClinicalTrials.gov website. As of May 25, 2021, there are five active investigational sites in the United States (Los Angeles, California; Minneapolis, Minnesota; New York City, New York; Cleveland, Ohio; Salt Lake City, Utah). Updated site information will be posted as it becomes available.

ASF invited a medical expert at Sanofi-Genzyme who designed the HERA clinical trial to speak to the larger Alport community about this ongoing study and to answer patients’ questions as part of a webinar held on June 30, 2021. You can watch a closed-captioned recording of the webinar at this link.

CARDINAL Study

Conducted by Reata Pharmaceuticals

STATUS

Fully enrolled; recruitment for Phase 3 closed Fall 2018.

STUDY UPDATE

DECEMBER 2022 UPDATE:

Effects of Bardoxolone Methyl in Alport Syndrome
Warady, Bradley A. et al.
CJASN, December 2022.

MARCH 10, 2022 UPDATE: As was communicated to investigators, coordinators, and study partners at clinical sites, Reata will continue to enroll patients in FALCON and continue to dose patients with Alport syndrome and ADPKD in EAGLE (the extended access study).

Read the full March 10, 2022 Press Release.

FEBRUARY 2022 UPDATE: On February 25, 2022, the U.S. Food and Drug Administration (FDA) announced its decision not to approve a New Drug Application for the use of bardoxolone methyl as a treatment for Alport syndrome. Bardoxolone methyl was investigated for safety and efficacy in Alport patients through the CARDINAL Study, the first-ever clinical trial for our rare disease.

Alport Syndrome Foundation has issued a press release and video message addressing the FDA’s decision.

February 25, 2022: “PLANO, Texas–(BUSINESS WIRE)– Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,” or “we”), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) regarding the New Drug Application (“NDA”) for bardoxolone methyl (“bardoxolone”) for the treatment of patients with chronic kidney disease (“CKD”) caused by Alport syndrome.”

VIEW THE FULL FEBRUARY 25, 2022 REATA PHARMACEUTICALS PRESS RELEASE

SUMMARY

The CARDINAL Study investigated bardoxolone methyl given as a once-daily oral medication that promotes normal mitochondrial function and potentially reduces kidney inflammation. Reata Pharmaceuticals has already completed prior studies of the drug for patients with chronic kidney disease (CKD) caused by type 2 diabetes, with favorable results. Currently the effectiveness of bardoxolone methyl is being tested on patients with Alport syndrome.

The Phase 2 CARDINAL Study was a  two-year commitment by patients and investigated how the drug affects the chronic inflammation and decline in kidney function that are key features of Alport syndrome. The Phase 2 portion of the study enrolled 30 patients who received the active drug.

The Phase 3 CARDINAL Study evaluated the drug bardoxolone methyl in Alport syndrome. This international study enrolled 150+ patients, who received the active drug or placebo. Participants received compensation and/or reimbursement for study-related time and travel, including flight or lodging costs. See “Study Update” at left for additional details and updated information about the Study.


EAGLE is an extended access study assessing the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is no longer available though the Study sponsor or until patient withdrawal, whichever is sooner.

On January 21, 2022, Reata Pharmaceuticals provided a written statement to ASF and the larger community of Alport syndrome patients and families regarding the EAGLE Study.

Kidney Response Phase 1 Study

Conducted by Regulus Therapeutics

SUMMARY

When active, the Phase 1 kidney response study was recruiting male and female participants with a diagnosis of Alport syndrome. When recruiting, all participants in this study were receiving the investigational drug. Travel and lodging assistance, along this in-home visits, were available.

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