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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)

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ClinicalTrials.gov Identifier: NCT03165227
Recruitment Status : Recruiting
First Posted : May 24, 2017
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Drug: BI 685509 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 4 Multiple Rising Oral Doses of BI 685509 Over 28 Days in Male and Female Patients With Diabetic Nephropathy
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Experimental: BI 685509 Dose 4 Drug: BI 685509
Taken orally
Placebo Comparator: Placebo Drug: Placebo
Taken orally



Primary Outcome Measures :
  1. Percentage of patients with drug related Adverse Events (AEs) [ Time Frame: Up to 35 days ]

Secondary Outcome Measures :
  1. Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in morning void urine [ Time Frame: Up to 28 days ]
  2. Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in 24-hour urine [ Time Frame: Up to 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 60 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) ≥ 6.5% and < 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 phosphodiesterase inhibitors, nitrates or riociguat, from screening (Visit 1) or within 5 half-lives before randomisation whatever is earlier. Concomitant treatment from screening (Visit 1) with glitazones, and repaglinide.
  • 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 enrolment 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165227


Contacts
Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, California
California Institute of Renal Research Recruiting
La Mesa, California, United States, 91942
Contact: George Fadda    +001 (619) 461-3894    gfadda@cairr.com   
United States, Colorado
Creekside Endocrine Associates, PC Recruiting
Denver, Colorado, United States, 80209
Contact: Leonard Zemel    +001 (303) 394-2888    zennylemel@aol.com   
United States, Florida
Innovative Research of West Florida, Inc. Recruiting
Clearwater, Florida, United States, 33756
Contact: Miguel Trevino    +001 (727) 584-8777    miguelt@innovativeresearchfl.com   
The Center for Diabetes and Endocrine Care Recruiting
Fort Lauderdale, Florida, United States, 33312
Contact: Sam Lerman    +001 (954) 963-7100    slerman@diabetes-endocare.com   
Indago Research and Health Center Recruiting
Hialeah, Florida, United States, 33012
Contact: Jose Cardona    +001 (305) 825-6588    jcardona@indagoresearch.org   
Ocean Blue Medical Research Center, Inc. Recruiting
Miami Springs, Florida, United States, 33166
Contact: Juan Rondon    +001 (305) 885-8983    juan.rondon@obmedresearch.com   
San Marcus Research Clinic, Inc. Recruiting
Miami, Florida, United States, 33015
Contact: Idalia Acosta    +001 (305) 424-7420    iacosta@sanmarcusrc.com   
United States, Illinois
Research by Design, LLC Recruiting
Chicago, Illinois, United States, 60643
Contact: Paul Crawford    +001 (708) 952-4644    pcrawford@researchbd.com   
United States, New York
Scott Research, Inc. Recruiting
Laurelton, New York, United States, 11413
Contact: David Scott    +001 (718) 276-4750    dscott@scottresearch.org   
United States, Texas
Research Institute of Dallas Recruiting
Dallas, Texas, United States, 75231
Contact: Stephen Aronoff    +001 (214) 265-2137    researcharonoff@yahoo.com   
Houston Clinical Research Associates Recruiting
Houston, Texas, United States, 77090
Contact: Mohammad Siddiqi    +001 (281) 650-1846    msiddiqi@hcratrials.com   
Science Advancing Medicine Clinical Research Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Sam Miller    +001 (210) 614-4800    sam@samcrc.com   
United States, Virginia
York Clinical Research, LLC Recruiting
Norfolk, Virginia, United States, 23510
Contact: Charles Lovell    +001 (757) 373-9478    lovellmdfacp@yorkclinicalresearch.com   
Belgium
Bonheiden - HOSP Imelda Recruiting
Bonheiden, Belgium, 2820
Contact: Chris Vercammen    +32 (0)15 50 51 64    chris.vercammen@imelda.be   
Brussels - UNIV UZ Brussel Recruiting
Brussel, Belgium, 1090
Contact: Corinne Debroye    +32 (0)2 474 93 97    corinne.debroye@uzbrussel.be   
Edegem - UNIV UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: Christophe De Block    +32 (0)3 821 32 76    christophe.de.block@uza.be   
UNIV UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Bruno Lapauw    +32 (0)9 332 21 38    Bruno.Lapauw@uzgent.be   
Centre Hospitalier Universitaire de Liège Recruiting
Liège, Belgium, 4000
Contact: Bernard Jandrain    +32 (0)4 366 83 06    bernard.jandrain@chu.ulg.ac.be   
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: David Cherney    416-340-4151    david.cherney@uhn.ca   
Germany
SocraTec R&D GmbH Recruiting
Erfurt, Germany, 99084
Contact: Frank Donath    493616020555    Frank.Donath@socratec-pharma.de   
Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03165227     History of Changes
Other Study ID Numbers: 1366-0004
2014-004541-27 ( EudraCT Number )
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases