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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03165227
Other study ID # 1366-0004
Secondary ID 2014-004541-27
Status Completed
Phase Phase 1
First received
Last updated
Start date October 17, 2017
Est. completion date December 10, 2019

Study information

Verified date January 2020
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date December 10, 2019
Est. primary completion date December 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Further exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BI 685509
Taken orally
Placebo
Taken orally

Locations

Country Name City State
Belgium Bonheiden - HOSP Imelda Bonheiden
Belgium Brussels - UNIV UZ Brussel Brussel
Belgium Edegem - UNIV UZ Antwerpen Edegem
Belgium UNIV UZ Gent Gent
Belgium Centre Hospitalier Universitaire de Liège Liège
Canada Toronto General Hospital Toronto Ontario
Czechia St. Anna Hospital, 2nd Internal Department Brno
Czechia University Hospital Brno Brno
Czechia Quinta Analytica Prague
Czechia General University Hospital in Prague Prague 6
Czechia Institute for Clinical and Experimental Medicine Praha 4
Germany SocraTec R&D GmbH Erfurt
Germany CTC North GmbH & Co. KG, Hamburg Hamburg
United States Research by Design, LLC Chicago Illinois
United States Innovative Research of West Florida, Inc. Clearwater Florida
United States Research Institute of Dallas Dallas Texas
United States Creekside Endocrine Associates, PC Denver Colorado
United States The Center for Diabetes and Endocrine Care Fort Lauderdale Florida
United States Indago Research and Health Center Hialeah Florida
United States Houston Clinical Research Associates Houston Texas
United States Nephrology Consultants, LLC Huntsville Alabama
United States Knoxville Kidney Center PLLC Knoxville Tennessee
United States California Institute of Renal Research La Mesa California
United States South Florida Research Institute Lauderdale Lakes Florida
United States Scott Research, Inc. Laurelton New York
United States Office of Dr. Richard S. Cherlin Los Gatos California
United States Boise Kidney and Hypertension Institute Meridian Idaho
United States San Marcus Research Clinic, Inc. Miami Florida
United States Ocean Blue Medical Research Center, Inc. Miami Springs Florida
United States Tulane University Hospital and Clinic New Orleans Louisiana
United States York Clinical Research, LLC Norfolk Virginia
United States Science Advancing Medicine Clinical Research Center San Antonio Texas
United States Northwest Louisiana Nephrology L.L.C. Shreveport Louisiana
United States Genesis Clinical Research Tampa Florida
United States PMG Research of Wilmington, LLC Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with drug related Adverse Events (AEs) Up to 35 days
Secondary Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in morning void urine Up to 28 days
Secondary Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in 10-hour urine Up to 28 days
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