UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039482 |
|---|---|
| Receipt number | 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 | 2024/02/06 09:36:11 |
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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 off-treatment change from baseline in eGFR) at Week 52 or following a 4-week drug treatment withdrawal period in the first year of treatment.
Key secondary outcomes
To assess the off-treatment change from baseline in eGFR at Week 104 or following a 4-week drug treatment withdrawal period in the second year of treatment.
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 <= 90 mmHg at Screen A visit after a period of rest.
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;
･Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan must have discontinued drug for at least 3 months prior to Screen A visit
Target sample size
550
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
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
clinical.info.jp@kyowakirin.com
Sponsor or person
Institute
Reata Pharmaceuticals, Inc.
Institute
Department
Personal name
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
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
国立大学法人北海道大学病院（北海道）
独立行政法人地域医療機能推進機構仙台病院（宮城県）
国立大学法人新潟大学医歯学総合病院（新潟県）
順天堂大学医学部附属順天堂医院（東京都）
東京女子医科大学病院（東京都）
国家公務員共済組合連合会虎の門病院（東京都）
国家公務員共済組合連合会虎の門病院分院（神奈川県）
国立大学法人大阪大学医学部附属病院（大阪府）
大阪市立大学医学部附属病院（大阪府）
地方独立行政法人大阪市民病院機構大阪市立総合医療センター（大阪府）
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
667
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
Terminated
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 | 07 | Month | 04 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 24 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 10 | Month | 23 | Day |
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
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045019
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