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)



Status:Recruiting
Conditions:Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:October 17, 2017
End Date:November 15, 2019
Contact:Boehringer Ingelheim
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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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

The main objective of this trial is the safety and tolerability of 4 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.


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
We found this trial at
19
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Shreveport, Louisiana 71101
Phone: +001 (318) 220-9792
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9 Imeldalaan
Bonheiden, 2820
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9730 South Western Avenue
Chicago, Illinois 60643
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Clearwater, Florida 33756
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Dallas, Texas 75231
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Denver, Colorado 80209
Phone: +001 (303) 394-2888
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Fort Lauderdale, Florida 33312
Phone: +001 (954) 963-7100
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Hialeah, Florida 33012
Phone: +001 (305) 825-6588
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6550 Fannin Street
Houston, Texas 77090
Phone: +001 (281) 650-1846
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La Mesa, California 91942
Phone: +001 (619) 461-3894
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232-01 Merrick Boulevard
Laurelton, New York 11413
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Los Gatos, California 95032
Phone: +001 (408) 358-2663
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Miami, Florida 33015
Phone: +001 (305) 424-7420
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Miami Springs, Florida 33166
Phone: +001 (305) 885-8983
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New Orleans, Louisiana 70112
Phone: +001 (504) 988-5044
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142 West York Street
Norfolk, Virginia 23510
Phone: +001 (757) 373-9478
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Roswell, Georgia 30076
Phone: +001 (678) 878-4750
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7979 Wurzbach Road
San Antonio, Texas 78229
Phone: +001 (210) 614-4800
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
Phone: +001 (910) 815-6108
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