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)

Phase 1

Completed

• Conditions: Diabetic Nephropathies
• Interventions: Drug: BI 685509; Drug: Placebo

• Registration Number: NCT03165227
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-24
• Study Start: 2017-10-17
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BI 685509 Dose 3	BI 685509	-
Placebo	Placebo	-
BI 685509 Dose 1	BI 685509	-
BI 685509 Dose 2	BI 685509	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with drug related Adverse Events (AEs)	Up to 35 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (35)

Indago Research and Health Center; 🇺🇸 Hialeah, Florida, United States

Research by Design, LLC; 🇺🇸 Chicago, Illinois, United States

Houston Clinical Research Associates; 🇺🇸 Houston, Texas, United States

Creekside Endocrine Associates, PC; 🇺🇸 Denver, Colorado, United States

San Marcus Research Clinic, Inc.; 🇺🇸 Miami, Florida, United States

Science Advancing Medicine Clinical Research Center; 🇺🇸 San Antonio, Texas, United States

Office of Dr. Richard S. Cherlin; 🇺🇸 Los Gatos, California, United States

Edegem - UNIV UZ Antwerpen; 🇧🇪 Edegem, Belgium

St. Anna Hospital, 2nd Internal Department; 🇨🇿 Brno, Czechia

University Hospital Brno; 🇨🇿 Brno, Czechia

CTC North GmbH & Co. KG, Hamburg; 🇩🇪 Hamburg, Germany

Knoxville Kidney Center PLLC; 🇺🇸 Knoxville, Tennessee, United States

UNIV UZ Gent; 🇧🇪 Gent, Belgium

Nephrology Consultants, LLC; 🇺🇸 Huntsville, Alabama, United States

California Institute of Renal Research; 🇺🇸 La Mesa, California, United States

The Center for Diabetes and Endocrine Care; 🇺🇸 Fort Lauderdale, Florida, United States

Innovative Research of West Florida, Inc.; 🇺🇸 Clearwater, Florida, United States

Ocean Blue Medical Research Center, Inc.; 🇺🇸 Miami Springs, Florida, United States

South Florida Research Institute; 🇺🇸 Lauderdale Lakes, Florida, United States

Boise Kidney and Hypertension Institute; 🇺🇸 Meridian, Idaho, United States

Quinta Analytica; 🇨🇿 Prague, Czechia

Scott Research, Inc.; 🇺🇸 Laurelton, New York, United States

Northwest Louisiana Nephrology L.L.C.; 🇺🇸 Shreveport, Louisiana, United States

PMG Research of Wilmington, LLC; 🇺🇸 Wilmington, North Carolina, United States

York Clinical Research, LLC; 🇺🇸 Norfolk, Virginia, United States

Research Institute of Dallas; 🇺🇸 Dallas, Texas, United States

Bonheiden - HOSP Imelda; 🇧🇪 Bonheiden, Belgium

Brussels - UNIV UZ Brussel; 🇧🇪 Brussel, Belgium

Centre Hospitalier Universitaire de Liège; 🇧🇪 Liège, Belgium

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

General University Hospital in Prague; 🇨🇿 Prague 6, Czechia

SocraTec R&D GmbH; 🇩🇪 Erfurt, Germany

Institute for Clinical and Experimental Medicine; 🇨🇿 Praha 4, Czechia

Genesis Clinical Research; 🇺🇸 Tampa, Florida, United States

Tulane University Hospital and Clinic; 🇺🇸 New Orleans, Louisiana, United States