This Study Tests a New Medicine Called BI 685509 in Patients That Have Kidney Problems Because of Diabetes. The Study Tests How BI 685509 is Taken up in the Body and How Well it is Tolerated (Multiple Rising Doses)
Randomised, Double-blind, Placebo-controlled Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Multiple Rising Oral Doses of BI 685509 Over 28 Days in Male and Female Patients With Diabetic Nephropathy
2 other identifiers
interventional
75
5 countries
35
Brief Summary
The main objective of this trial is the safety and tolerability of 3 multiple rising oral doses of BI 685509 over 28 days in male and female patients with Diabetic Nephropathy (DN) as adjunctive to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). Another objective is the change in Urine Albumin Creatinine Ratio (UACR), an important diagnostic marker of nephropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2017
Typical duration for phase_1
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedStudy Start
First participant enrolled
October 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2019
CompletedJanuary 13, 2020
January 1, 2020
2.1 years
May 23, 2017
January 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with drug related Adverse Events (AEs)
Up to 35 days
Secondary Outcomes (2)
Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in morning void urine
Up to 28 days
Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in 10-hour urine
Up to 28 days
Study Arms (4)
BI 685509 Dose 1
EXPERIMENTALBI 685509 Dose 2
EXPERIMENTALBI 685509 Dose 3
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male or postmenopausal (last menstruation ≥ 2 years ago) patients, or female patients who are sterilized by either hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy. Male patients with partners of child-bearing potential must be willing to use condoms from the time of the first intake of study drug until follow-up.
- eGFR (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) ≥ 20 and \< 75 ml/min/1.73 m2 at Visit 1 measured by the central laboratory and no planned start of renal replacement therapy during the trial
- UACR ≥ 200 and \<3500 mg/g in spot urine (midstream urine sample) at Visit 1 measured by the central laboratory
- Treatment with either ACEi or ARB, stable dose since ≥ 4 weeks before Visit 1 with no planned change of the therapy
- Patients with type 1 or type 2 diabetes mellitus, diagnosed before informed consent and treated with insulin, glucagon-like peptide (GLP) 1 agonists and/or oral antidiabetic medication. Treatment should have been unchanged (investigator's judgment) within 4 weeks before Visit 1 and until randomisation
- Glycated Haemoglobin (HbA1c) \< 10.0% at Visit 1 measured by the central laboratory
- Seated Systolic Blood Pressure (SBP) ≥ 110 and ≤ 180 mmHg and Diastolic Blood Pressure (DBP) ≥ 70 and ≤ 110 mmHg at Visit 1
- Age at screening ≥ 18 years for male and permanently sterilized female patients and ≥ 45 years for postmenopausal female patients
- Body Mass Index (BMI) ≥ 18.5 and \< 45 kg/m2
- Successful ABPM reading before randomisation, upper arm circumference within the circumference level of the cuff size of either ABPM and/or BP measurement device used in the study
You may not qualify if:
- Treatment with SGLT2 inhibitors and/or phosphodiesterase inhibitors, nitrates or riociguat, from screening (Visit 1) or within 5 half-lives before randomisation whatever is earlier.
- Any laboratory value more than 3 times above upper limit of normal (ULN) at screening (Visit 1) or any other laboratory value outside the reference range and clinically relevant (for safe participation) in the investigator judgment
- Confirmed non-diabetic renal disease in the opinion of investigator
- Any other medical condition that in the investigator's opinion poses a safety risk for the patient or may interfere with the study objectives including
- symptomatic heart failure (NYHA III/IV),
- known history of tachycardia and/or atrial fibrillation
- clinically relevant arrhythmias
- coronary heart disease not compensated by medical treatment (supine pulse rate \>70 beats per minute, existing angina pectoris)
- \<6 months after myocardial infarction.
- Medical history of cancer or treatment for cancer in the last two years prior to Visit 1 (except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, and prostatic cancer of low grade \[T1 or T2\] is exempted)
- Surgery or trauma with significant blood loss (investigator's judgement) within the last 3 months prior to informed consent or significant blood donation (investigator's judgement) within four weeks prior to first administration of study medication or planned during the trial
- Previous randomization in this trial
- Currently enrolled in another investigational device or drug study, i.e., less than 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s)
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable study subject or unlikely to complete the trial
- Women of childbearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Nephrology Consultants, LLC
Huntsville, Alabama, 35805, United States
California Institute of Renal Research
La Mesa, California, 91942, United States
Office of Dr. Richard S. Cherlin
Los Gatos, California, 95032, United States
Creekside Endocrine Associates, PC
Denver, Colorado, 80246, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312, United States
Indago Research and Health Center
Hialeah, Florida, 33012, United States
South Florida Research Institute
Lauderdale Lakes, Florida, 33313, United States
San Marcus Research Clinic, Inc.
Miami, Florida, 33014, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, 33166, United States
Genesis Clinical Research
Tampa, Florida, 33614, United States
Boise Kidney and Hypertension Institute
Meridian, Idaho, 83642, United States
Research by Design, LLC
Chicago, Illinois, 60643, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112, United States
Northwest Louisiana Nephrology L.L.C.
Shreveport, Louisiana, 71101, United States
Scott Research, Inc.
Laurelton, New York, 11413, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Knoxville Kidney Center PLLC
Knoxville, Tennessee, 37923, United States
Research Institute of Dallas
Dallas, Texas, 75231, United States
Houston Clinical Research Associates
Houston, Texas, 77090, United States
Science Advancing Medicine Clinical Research Center
San Antonio, Texas, 78229, United States
York Clinical Research, LLC
Norfolk, Virginia, 23510, United States
Bonheiden - HOSP Imelda
Bonheiden, 2820, Belgium
Brussels - UNIV UZ Brussel
Brussels, 1090, Belgium
Edegem - UNIV UZ Antwerpen
Edegem, 2650, Belgium
UNIV UZ Gent
Ghent, 9000, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
University Hospital Brno
Brno, 625 00, Czechia
St. Anna Hospital, 2nd Internal Department
Brno, 656 91, Czechia
Quinta Analytica
Prague, 10200, Czechia
Institute for Clinical and Experimental Medicine
Prague, 140 21, Czechia
General University Hospital in Prague
Prague, 169 00, Czechia
SocraTec R&D GmbH
Erfurt, 99084, Germany
CTC North GmbH & Co. KG, Hamburg
Hamburg, 20251, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2017
First Posted
May 24, 2017
Study Start
October 17, 2017
Primary Completion
December 10, 2019
Study Completion
December 10, 2019
Last Updated
January 13, 2020
Record last verified: 2020-01