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)

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Completed

CT.gov ID

NCT03165227

Collaborator

(none)

Enrollment

Locations

Arms

25.8

Actual Duration (Months)

2.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathies	Drug: BI 685509 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 17, 2017

Actual Primary Completion Date :

Dec 10, 2019

Actual Study Completion Date :

Dec 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BI 685509 Dose 1	Drug: BI 685509 Taken orally
Experimental: BI 685509 Dose 2	Drug: BI 685509 Taken orally
Experimental: BI 685509 Dose 3	Drug: BI 685509 Taken orally
Placebo Comparator: Placebo	Drug: Placebo Taken orally

Outcome Measures

Primary Outcome Measures

Percentage of patients with drug related Adverse Events (AEs) [Up to 35 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nephrology Consultants, LLC	Huntsville	Alabama	United States	35805
2	California Institute of Renal Research	La Mesa	California	United States	91942
3	Office of Dr. Richard S. Cherlin	Los Gatos	California	United States	95032
4	Creekside Endocrine Associates, PC	Denver	Colorado	United States	80246
5	Innovative Research of West Florida, Inc.	Clearwater	Florida	United States	33756
6	The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida	United States	33312
7	Indago Research and Health Center	Hialeah	Florida	United States	33012
8	South Florida Research Institute	Lauderdale Lakes	Florida	United States	33313
9	Ocean Blue Medical Research Center, Inc.	Miami Springs	Florida	United States	33166
10	San Marcus Research Clinic, Inc.	Miami	Florida	United States	33014
11	Genesis Clinical Research	Tampa	Florida	United States	33614
12	Boise Kidney and Hypertension Institute	Meridian	Idaho	United States	83642
13	Research by Design, LLC	Chicago	Illinois	United States	60643
14	Tulane University Hospital and Clinic	New Orleans	Louisiana	United States	70112
15	Northwest Louisiana Nephrology L.L.C.	Shreveport	Louisiana	United States	71101
16	Scott Research, Inc.	Laurelton	New York	United States	11413
17	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
18	Knoxville Kidney Center PLLC	Knoxville	Tennessee	United States	37923
19	Research Institute of Dallas	Dallas	Texas	United States	75231
20	Houston Clinical Research Associates	Houston	Texas	United States	77090
21	Science Advancing Medicine Clinical Research Center	San Antonio	Texas	United States	78229
22	York Clinical Research, LLC	Norfolk	Virginia	United States	23510
23	Bonheiden - HOSP Imelda	Bonheiden		Belgium	2820
24	Brussels - UNIV UZ Brussel	Brussel		Belgium	1090
25	Edegem - UNIV UZ Antwerpen	Edegem		Belgium	2650
26	UNIV UZ Gent	Gent		Belgium	9000
27	Centre Hospitalier Universitaire de Liège	Liège		Belgium	4000
28	Toronto General Hospital	Toronto	Ontario	Canada	M5G 2C4
29	University Hospital Brno	Brno		Czechia	625 00
30	St. Anna Hospital, 2nd Internal Department	Brno		Czechia	656 91
31	General University Hospital in Prague	Prague 6		Czechia	169 00
32	Quinta Analytica	Prague		Czechia	10200
33	Institute for Clinical and Experimental Medicine	Praha 4		Czechia	140 21
34	SocraTec R&D GmbH	Erfurt		Germany	99084
35	CTC North GmbH & Co. KG, Hamburg	Hamburg		Germany	20251

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT03165227

Other Study ID Numbers:

1366-0004
2014-004541-27

First Posted:

May 24, 2017

Last Update Posted:

Jan 13, 2020

Last Verified:

Jan 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Diabetic Nephropathies

Study Results

No Results Posted as of Jan 13, 2020