ADPKD Clinical Trial
— FALCONOfficial title:
A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease
Verified date | June 2024 |
Source | Biogen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This international, multi-center, randomized, double-blind, placebo-controlled Phase 3 trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD. Approximately 850 patients will be enrolled.
Status | Terminated |
Enrollment | 667 |
Est. completion date | August 8, 2023 |
Est. primary completion date | August 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 70 Years |
Eligibility | Inclusion Criteria: - Male and female patients 12 = age = 70 upon study consent; - Diagnosis of ADPKD by modified Pei-Ravine criteria (for adults 18= age =70 years): 1) at least 3 cysts per kidney by sonography or at least 5 cysts by CT or MRI with family history of ADPKD or 2) at least 10 cysts per kidney by any radiologic method and exclusion of other cystic kidney diseases if without family history; - Screening eGFR (average of Screen A and Screen B eGFR values) = 30 to= 90 mL/min/1.73 m2 (12 to 55 years) or = 30 to = 44 mL/min/1.73 m2 (56 to 70 years): 1) Patients with either screening eGFR = 60 to = 90 mL/min/1.73 m2 or age 56 to 70 years, must have evidence of ADPKD progression (i.e., eGFR decline of = 2.0 mL/min/1.73 m2 per year, based on historical eGFR data and medical monitor discretion); 2)The two eGFR values collected at Screen A and Screen B visits used to determine eligibility must have a percent difference = 25%; - Albumin to creatinine ratio (ACR) = 2500 mg/g at Screen B visit; - Systolic blood pressure = 140 mmHg and diastolic blood pressure = 90 mmHg at Screen A or B visit after a period of rest. Exclusion Criteria: - History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 2 months prior to the Screen A visit; - B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit; - Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit; - Serum albumin < 3 g/dL at Screen A visit; - History of intracranial aneurysms; - Kidney or any other solid organ transplant recipient or a planned transplant during the study; - Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening; - History of clinically significant left-sided heart disease and/or clinically significant cardiac disease; - Systolic BP < 90 mm Hg at Screen A visit after a period of rest; - BMI < 18.5 kg/m2 at the Screen A visit; - History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas; - Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study; - Untreated or uncontrolled active bacterial, fungal, or viral infection; - Participation in other interventional clinical studies within 30 days prior to Day 1; - Unwilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested; - Women who are pregnant or breastfeeding; - Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan must have discontinued drug for at least 2 months prior to Screen A visit |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | South Australia |
Australia | Sunshine Coast University Hospital | Birtinya | Queensland |
Australia | Monash Health | Clayton | Victoria |
Australia | Renal Research | Gosford | New South Wales |
Australia | Royal Brisbane and Women's Hospital | Herston | Queensland |
Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
Australia | John Hunter Hospital | New Lambton | New South Wales |
Australia | Melbourne Health | Parkville | Victoria |
Australia | Melbourne Renal Research Group | Reservoir | Victoria |
Australia | Westmead Hospital | Sydney | New South Wales |
Belgium | Nephrology, Cliniques U St-Luc | Brussels | |
Belgium | Universitair Ziekenhuis Brussel (VUB) | Brussels | |
Belgium | University Hospitals Leuven, Dept. of Nephrology, Dialysis and Renal Transplantation | Leuven | |
Belgium | Chu Liege | Liège | |
Czechia | FN Brno | Brno | |
Czechia | Nephrology Dept., General Teaching Hospital | Prague | |
Czechia | IKEM | Praha | |
France | University Hospital La Cavale Blanche | Brest | |
France | Chu Grenoble Alpes | Grenoble | |
France | Hospital Henri-Mondor AP-HP | Le Kremlin-Bicêtre | |
France | CHU de Nantes | Nantes | |
France | Hopital Necker, Universite Paris Descartes | Paris | |
Germany | Universitätsklinikum Essen | Essen | |
Germany | Medizinische Hochschule Hannover | Hanover | |
Germany | Klinikum rechts der Isar der TU München | München | |
Italy | Renal Division, ASST Santi Paolo e Carlo | Milan | |
Italy | Università di Modena e Reggio Emilia | Modena | |
Italy | ICS Maugeri SpA SB | Pavia | |
Italy | Fondazione Policlinico Gemelli | Roma | |
Japan | Hokkaido University Hospital | Hokkaido | |
Japan | Toranomon Hospital Kajigaya | Kanagawa | |
Japan | Japan Community Healthcare Organization Sendai Hospital | Miyagi | |
Japan | Niigata University Medical & Dental Hospital | Niigata | |
Japan | Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital | Osaka | |
Japan | Osaka City University Hospital | Osaka | |
Japan | Osaka University Hospital | Osaka | |
Japan | Juntendo University Hospital | Tokyo | |
Japan | Tokyo Women's Medical University Hospital | Tokyo | |
Japan | Toranomon Hospital | Tokyo | |
Spain | Hospital Universitario de Badajoz | Badajoz | |
Spain | Fundacio Puigvert | Barcelona | |
Spain | Hospital Del Mar | Barcelona | |
Spain | Hospital Universitario Reina Sofía | Córdoba | |
Spain | Hospital Universitario Virgen de las Nieves | Granada | |
Spain | Hospital Lucus Augusti | Lugo | |
Spain | Fundación Jiménez Díaz | Madrid | |
Spain | Hospital de Getafe | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Marques de Valdecilla | Santander | |
Spain | Hospital Universitario Dr Peset | Valencia | |
United Kingdom | North Bristol NHS Trust | Bristol | |
United Kingdom | Manchester University NHS Foundation Trust | Manchester | |
United Kingdom | Nottingham University Hospitals | Nottingham | |
United Kingdom | Morriston Hospital | Swansea | |
United States | TTUHSC | Amarillo | Texas |
United States | Arlington Nephrology, PA | Arlington | Texas |
United States | Western Nephrology | Arvada | Colorado |
United States | Mountain Kidney & Hypertension Associates | Asheville | North Carolina |
United States | Emory University | Atlanta | Georgia |
United States | University of Colorado Anschutz Medical Center | Aurora | Colorado |
United States | Research Management, Inc. | Austin | Texas |
United States | Research Management, Inc. | Austin | Texas |
United States | The Johns Hopkins University | Baltimore | Maryland |
United States | University of Maryland School of Medicine | Baltimore | Maryland |
United States | Renal Associates of Baton Rouge | Baton Rouge | Louisiana |
United States | Northeast Clinical Research Center | Bethlehem | Pennsylvania |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Boise Kidney & Hypertension, PLLC | Caldwell | Idaho |
United States | Metrolina Nephrology Associates | Charlotte | North Carolina |
United States | University of Virginia | Charlottesville | Virginia |
United States | Northwestern University | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | Cincinnati VA Medical Center | Cincinnati | Ohio |
United States | University of Cincinnati College of Medicine | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Columbia Nephrology Associates, PA | Columbia | South Carolina |
United States | Remington-Davis Clinical Research | Columbus | Ohio |
United States | Liberty Research Center | Dallas | Texas |
United States | Renal Disease Research Institute | Dallas | Texas |
United States | Denver Nephrologist, PC | Denver | Colorado |
United States | Kidney Associates of Colorado | Denver | Colorado |
United States | Rancho Research Institute | Downey | California |
United States | Davita Clinical Research | El Paso | Texas |
United States | Nephrology Associates of Northern Virginia, Inc. | Fairfax | Virginia |
United States | Nephrology Associates, P.C. | Flushing | New York |
United States | AKDHC | Glendale | Arizona |
United States | Division of Kidney Diseases and Hypertension | Great Neck | New York |
United States | Nephrology Associates PC | Homewood | Alabama |
United States | DaVita Med Center | Houston | Texas |
United States | Nephrology Consultants, LLC | Huntsville | Alabama |
United States | Paragon Health PC d/b/a Nephrology Center PC | Kalamazoo | Michigan |
United States | Clinical Research Consultants, LLC | Kansas City | Missouri |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | California Institute Renal Research | La Mesa | California |
United States | KSOSN | Las Vegas | Nevada |
United States | Georgia Nephrology, LLC | Lawrenceville | Georgia |
United States | Keck USC/LAC | Los Angeles | California |
United States | University of California, Los Angeles | Los Angeles | California |
United States | Loyola University Chicago | Maywood | Illinois |
United States | Boise Kidney & Hypertension, PLLC | Meridian | Idaho |
United States | Aventiv Research, Inc | Mesa | Arizona |
United States | University of Miami | Miami | Florida |
United States | Pro-Care Research Center, Corp. | Miami Gardens | Florida |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | NYU Winthrop Hospital | Mineola | New York |
United States | Nephrology Associates, P.C. | Nashville | Tennessee |
United States | Yale University School of Medicine | New Haven | Connecticut |
United States | Amicis Research Center | Northridge | California |
United States | Discovery Medical Research Group | Ocala | Florida |
United States | Innovation Medical Research Center, Inc | Palmetto Bay | Florida |
United States | Stanford University | Palo Alto | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Michigan Kidney Consultants | Pontiac | Michigan |
United States | Volunteer Medical Research | Port Charlotte | Florida |
United States | North Carolina Nephrology, P.A. 2nd Floor | Raleigh | North Carolina |
United States | Apex Research of Riverside | Riverside | California |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Washington University in St. Louis | Saint Louis | Missouri |
United States | Clinical Advancement Center | San Antonio | Texas |
United States | University of California San Francisco | San Francisco | California |
United States | Swedish Medical Center | Seattle | Washington |
United States | Northwest Louisiana Nephrology | Shreveport | Louisiana |
United States | KidneyCare and Tranplant Services of New England | Springfield | Massachusetts |
United States | Renal and Transplant Associates of New England, PC | Springfield | Massachusetts |
United States | University of South Florida | Tampa | Florida |
United States | Cotton O'Neil Clinical Research Center | Topeka | Kansas |
United States | University of Arizona | Tucson | Arizona |
United States | Milwaukee Nephrologists, SC | Wauwatosa | Wisconsin |
United States | Western Nephrology and Mineral Bone Disease, PC | Westminster | Colorado |
United States | Ascension Via Christi Research | Wichita | Kansas |
United States | Kansas Nephrology Research Institute, LLC | Wichita | Kansas |
United States | Brookview Hills Research Associates, LLC | Winston-Salem | North Carolina |
United States | Florida Premier Research Institute, LLC | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Reata, a wholly owned subsidiary of Biogen |
United States, Australia, Belgium, Czechia, France, Germany, Italy, Japan, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Off-treatment Period: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 108 | Estimated Glomerular filtration rate (eGFR) is a measure of kidney function assessed through blood/serum. eGFR was measured in milliliters per minute per 1.73 meters square (mL/min/1.73 m^2). Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function. Negative change from baseline in eGFR indicates worsened kidney function. | Baseline, Week 108 | |
Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | AE:any untoward medical occurrence in a participant regardless of its causal relationship to study drug.AE can be any unfavorable & unintended sign,symptom/disease temporally associated with use of study drug,whether considered to be study-drug related/not.This includes clinically significant abnormal laboratory test result,any newly occurring events/previous conditions that have increased in severity/frequency since administration of study drug. SAE:any AE that at any dose results in death,life-threatening,requires hospitalization/prolongation of existing hospitalisation,substantial disruption of ability to conduct normal life functions,congenital anomaly or is an important medical event. AEs & SAEs that occurred during treatment and within 30 days after last dose were considered TE. | From first dose of the study drug up to end of follow-up (up to Week 112) | |
Secondary | Treatment Period: Change From Baseline in eGFR at Week 100 | eGFR is a measure of kidney function assessed through blood/serum. eGFR was measured in mL/min/1.73 m^2. Higher eGFRs represent better/improved kidney function. Lower eGFRs represent poorer/decreased kidney function. A negative change from baseline in eGFR indicates worsened kidney function. | Baseline, Week 100 |
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