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A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Chronic Kidney Disease Who do Not Have Diabetes

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ClinicalTrials.gov Identifier: NCT04736628
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

This study is open to adults who have kidney disease and do not have diabetes. The purpose of the study is to find out whether a medicine called BI 685509 improves kidney function. Three different doses of BI 685509 are tested in this study.

Participants get either one of the three doses of BI 685509 or placebo. It is decided by chance who gets which BI 685509 dose and who gets placebo. Participants take BI 685509 or placebo as tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants continue taking their usual medicine for kidney disease throughout the study.

Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call.

Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of BI 685509 and placebo. During the study, the doctors also regularly check the general health of the participants.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: BI 685509 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind (Within Dose Groups), Placebo Controlled and Parallel Group Trial to Investigate the Effects of Different Doses of Oral BI 685509 Given Over 20 Weeks on UACR Reduction in Patients With Non-diabetic Kidney Disease.
Actual Study Start Date : April 27, 2021
Estimated Primary Completion Date : July 19, 2022
Estimated Study Completion Date : August 16, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Dose group 1: BI 685509
Low dose.
Drug: BI 685509
BI 685509

Placebo Comparator: Dose group 1: Matching placebo
Matching placebo for low dose.
Drug: Placebo
Placebo

Experimental: Dose group 2: BI 685509
Low dose followed by up-titration to medium dose.
Drug: BI 685509
BI 685509

Placebo Comparator: Dose group 2: Matching placebo
Matching placebo for low dose followed by up-titration to medium dose.
Drug: Placebo
Placebo

Experimental: Dose group 3: BI 685509
Low dose followed by up-titration to medium dose, followed by up-titration to high-dose.
Drug: BI 685509
BI 685509

Placebo Comparator: Dose group 3: Matching placebo
Matching placebo for low dose followed by up-titration to medium dose, followed by up-titration to high dose.
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment. [ Time Frame: Up to 20 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in log transformed UACR measured in First Morning Void urine after 20 weeks of trial treatment. [ Time Frame: Up to 20 weeks ]
  2. Proportion of patients achieving UACR decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment. [ Time Frame: Up to 20 weeks ]
  3. Proportion of patients achieving UACR decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment. [ Time Frame: Up to 20 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  • Male or female patients aged = 18 years at time of consent
  • Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 20 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis
  • Urine albumin creatinine ratio (UACR) ≥ 200 and < 3,500 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1
  • Patients with macroalbuminuria (>300 mg/g) should be treated with the highest tolerated dose of either Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both). For patients with microalbuminuria the use of ACEi or ARB is at the discretion of the Investigator. Treatment should be at a stable dose for ≥ 4 weeks before Visit 1 with no planned change of the therapy during the trial.
  • Stable on anti-hypertensives, Non-steroidal anti-inflammatory drug(s) (NSAIDs), endothelin receptor antagonists, systemic steroids or SGLT2 inhibitors, within at least 4 weeks prior to visit 1 until start of treatment, with no planned change of the therapy during the trial
  • Diagnosis of Chronic Kidney Disease (CKD) as defined by Kidney Disease: Improving Global Outcomes (KDIGO) definition
  • In the Investigator's opinion:

    • Hypertensive kidney disease OR
    • Chronic glomerulonephritis defined as one of the following:

      • Immunoglobulin A (IgA) nephropathy
      • Membranous nephropathy
      • Focal Segmental Glomerulosclerosis (FSGS)
  • Further inclusion criteria apply

Exclusion Criteria:

  • Treatment with Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either ACEi or ARB), phosphodiesterase inhibitors, nitrates, soluble Guanylate Cyclase (sGC)-stimulators/activators(other than trial treatment) or any other restricted medication (including Organic Anion-Transporting Polypeptide 1B1 and 1B3 (OATP1B1/3) inhibitors, Uridine 5'-diphosphate -glucuronosyltransferase (UGT) inhibitors/inducers) as provided in the Investigator Site File (ISF) within 4 weeks prior to visit 1 and throughout screening and baseline run-in. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
  • Any clinically relevant laboratory value from screening until start of trial treatment which, in the investigator's judgement, puts the patient at additional risk
  • Diabetes mellitus
  • Any immunosuppression therapy or immunotherapy in last 3 months prior to visit 1 and throughout screening and baseline run-in (except prednisolone ≤10 mg or equivalent)
  • Acute kidney injury (AKI) according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition in the 30 days prior to Visit 1 until the start of trial treatment
  • Planned start of chronic renal replacement therapy during the trial or end stage renal disease before start of trial treatment
  • Known history of moderate or severe symptomatic orthostatic dysregulation as judged by the investigator before start of trial treatment
  • The patient has an active infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (or is known to have a positive test from screening until randomisation)
  • Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736628


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, Connecticut
Chase Medical Research, LLC Recruiting
Waterbury, Connecticut, United States, 06708
Contact: Joseph Soufer    +001 (203) 419-4420    jsoufer@chasemr.com   
United States, Florida
Indago Research and Health Center Recruiting
Hialeah, Florida, United States, 33012
Contact: Jose Cardona    +001 (305) 825-6588    jcardona@indagoresearch.org   
United States, Texas
Texas Institute for Kidney and Endocrine Disorders Recruiting
Lufkin, Texas, United States, 75904
Contact: Lance Sloan    +001 (936) 414-3636    tikedlufkin@gmail.com   
Australia, New South Wales
Renal Research, Gosford Recruiting
Gosford, New South Wales, Australia, 2250
Contact: Simon Roger    +61 2 4323 7977    simon@renalresearch.com.au   
China
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Minghui Zhao    13501243815    Zhaomh20212021@163.com   
New Zealand
P3 Research Recruiting
Tauranga, New Zealand, 3110
Contact: Katrina Allen    +64 7 579 0453    KatrinaA@p3research.co.nz   
P3 Research Waikanae Recruiting
Waikanae, New Zealand, 5036
Contact: Nicola Pointing    64 4 908 1001    NicolaP@p3research.co.nz   
Spain
Hospital Clínico de Valencia Recruiting
Valencia, Spain, 46010
Contact: Jose Luis Gorriz Teruel    +34961973811    jlgorriz@gmail.com   
Hospital Dr. Peset Recruiting
Valencia, Spain, 46017
Contact: Veronica Escudero Quesada    +34961622456    veesque@gmail.com   
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04736628    
Other Study ID Numbers: 1366-0022
2020-002930-33 ( EudraCT Number )
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
URL: https://www.mystudywindow.com/msw/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency