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)

NCT ID: NCT03165227

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2019-12-10

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.

Conditions

Diabetic Nephropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 685509 Dose 1

Group Type: EXPERIMENTAL

BI 685509

Intervention Type: DRUG

Taken orally

BI 685509 Dose 2

Group Type: EXPERIMENTAL

BI 685509

Intervention Type: DRUG

Taken orally

BI 685509 Dose 3

Group Type: EXPERIMENTAL

BI 685509

Intervention Type: DRUG

Taken orally

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Taken orally

Interventions

BI 685509

Taken orally

Intervention Type: DRUG

Placebo

Taken orally

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nephrology Consultants, LLC

Huntsville, Alabama, United States

California Institute of Renal Research

La Mesa, California, United States

Office of Dr. Richard S. Cherlin

Los Gatos, California, United States

Creekside Endocrine Associates, PC

Denver, Colorado, United States

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

The Center for Diabetes and Endocrine Care

Fort Lauderdale, Florida, United States

Indago Research and Health Center

Hialeah, Florida, United States

South Florida Research Institute

Lauderdale Lakes, Florida, United States

San Marcus Research Clinic, Inc.

Miami, Florida, United States

Ocean Blue Medical Research Center, Inc.

Miami Springs, Florida, United States

Genesis Clinical Research

Tampa, Florida, United States

Boise Kidney and Hypertension Institute

Meridian, Idaho, United States

Research by Design, LLC

Chicago, Illinois, United States

Tulane University Hospital and Clinic

New Orleans, Louisiana, United States

Northwest Louisiana Nephrology L.L.C.

Shreveport, Louisiana, United States

Scott Research, Inc.

Laurelton, New York, United States

PMG Research of Wilmington, LLC

Wilmington, North Carolina, United States

Knoxville Kidney Center PLLC

Knoxville, Tennessee, United States

Research Institute of Dallas

Dallas, Texas, United States

Houston Clinical Research Associates

Houston, Texas, United States

Science Advancing Medicine Clinical Research Center

San Antonio, Texas, United States

York Clinical Research, LLC

Norfolk, Virginia, United States

Bonheiden - HOSP Imelda

Bonheiden, , Belgium

Brussels - UNIV UZ Brussel

Brussels, , Belgium

Edegem - UNIV UZ Antwerpen

Edegem, , Belgium

UNIV UZ Gent

Ghent, , Belgium

Centre Hospitalier Universitaire de Liège

Liège, , Belgium

Toronto General Hospital

Toronto, Ontario, Canada

University Hospital Brno

Brno, , Czechia

St. Anna Hospital, 2nd Internal Department

Brno, , Czechia

Quinta Analytica

Prague, , Czechia

Institute for Clinical and Experimental Medicine

Prague, , Czechia

General University Hospital in Prague

Prague, , Czechia

SocraTec R&D GmbH

Erfurt, , Germany

CTC North GmbH & Co. KG, Hamburg

Hamburg, , Germany

Countries

United States; Belgium; Canada; Czechia; Germany

Other Identifiers

2014-004541-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1366-0004

Identifier Type: -

Identifier Source: org_study_id