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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039482
Receipt No. R000045019
Scientific Title A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease
Date of disclosure of the study information 2020/02/14
Last modified on 2020/02/14

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Basic information
Public title A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease
Acronym A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON (FALCON)
Scientific Title A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease
Scientific Title:Acronym A Trial of Bardoxolone Methyl in Patients With ADPKD - FALCON (FALCON)
Region
Japan North America Australia
Europe

Condition
Condition Autosomal Dominant Polycystic Kidney Disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with ADPKD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes To assess the change in eGFR value from baseline to week 52, including a 4-week drug treatment withdrawal period, for patients receiving active drug, compared to patients receiving placebo.
Key secondary outcomes To assess the change in eGFR value from baseline to week 104, including a 4-week drug treatment withdrawal period, for patients receiving active drug, compared to patients receiving placebo.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bardoxolone methyl
Interventions/Control_2 Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria ・Male and female patients 18 <= age <= 70 upon study consent;
・Diagnosis of ADPKD by modified Pei-Ravine criteria:
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 (18 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 <= 80 mmHg at Screen A visit after a period of rest. Patients receiving an angiotensin-converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) must be on a stable dose for at least 6 weeks prior to the Screen A visit.
Key exclusion criteria ・History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 3 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;
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Lacey
Middle name
Last name Powers
Organization Reata Pharmaceuticals, Inc.
Division name Clinical Program Operations
Zip code 75063
Address 2801 Gateway Drive, Suite 150 Irving, TX
TEL +1-469-442-4837
Email Lacey.Powers@reatapharma.com

Public contact
Name of contact person
1st name -
Middle name
Last name Clinical trial information contact
Organization Kyowa Kirin Co., Ltd.
Division name R&D Planning Department, R&D Division
Zip code 100-0004
Address 1-9-2 Otemachi, Chiyoda-ku, Tokyo
TEL 03-5205-7200
Homepage URL
Email clinical.info.jp@kyowakirin.com

Sponsor
Institute Reata Pharmaceuticals, Inc.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kyowa Kirin Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Hospital Institutional Review Board
Address Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Tel 011-706-7061
Email tiken@med.hokudai.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT03918447
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 12 Month 12 Day
Date of IRB
2019 Year 12 Month 24 Day
Anticipated trial start date
2019 Year 05 Month 29 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Target sample size and Anticipated trial start date are global information. Japanese status is different from them.

Management information
Registered date
2020 Year 02 Month 14 Day
Last modified on
2020 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045019

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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