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Trial record 16 of 24 for:    eplerenone | Open Studies

This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 5 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2017 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT03165240
First received: May 23, 2017
Last updated: NA
Last verified: May 2017
History: No changes posted
  Purpose

The primary objective of this current trial is to investigate the safety and tolerability of 5 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor blockers [ARB].

Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio [UACR].


Condition Intervention Phase
Diabetic Nephropathies
Drug: BI 690517
Drug: Eplerenone
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled (Within Dose Groups) and Active Controlled (Eplerenone Group) Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 5 Oral Doses of BI 690517 Over 28 Days in Female and Male Patients With Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Safety and tolerability of BI 690517 is the percentage of patients with drug related Adverse Events (AEs) [ Time Frame: Up to 35 days ]

Secondary Outcome Measures:
  • Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) [ Time Frame: Up to 28 days ]
    The term "baseline" refers to the last observation prior to the first intake of trial medication


Estimated Enrollment: 126
Anticipated Study Start Date: July 12, 2017
Estimated Study Completion Date: July 15, 2018
Estimated Primary Completion Date: July 11, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 690517 Dose 1 Drug: BI 690517
Film-coated tablet
Experimental: BI 690517 Dose 2 Drug: BI 690517
Film-coated tablet
Experimental: BI 690517 Dose 3 Drug: BI 690517
Film-coated tablet
Experimental: BI 690517 Dose 4 Drug: BI 690517
Film-coated tablet
Experimental: BI 690517 Dose 5 Drug: BI 690517
Film-coated tablet
Experimental: Eplerenone Drug: Eplerenone
Film-coated tablet
Placebo Comparator: Placebo Drug: Placebo
Film-coated tablet

  Eligibility

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 12 weeks before Visit 1 and until randomisation.
  • Glycated Haemoglobin (HbA1c) ≥ 6.5% and < 10.0% at Visit 1 measured by the central laboratory.
  • Seated SBP ≥ 110 and ≤ 180 mmHg and 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.

Exclusion Criteria:

  • Treatment with inhibitors of aldosterone mediated effects like mineralocorticoid receptor antagonists at visit 1 and thereafter.
  • Intake of potassium supplements during the study (this period starts at Visit 1).
  • At Visit 1 cortisol peak level 30 minutes (± 10 min) after iv injection of ACTH < 500 nmol/l (180 μg/l).
  • Dual or triple blockade of the Renin Angiotensin System (RAS) (e.g. ACEi + ARB; ACEi + renin inhibitor; or ARB + renin inhibitor; or ACEi + ARB + renin inhibitor) 12 weeks before Visit 1 and for the duration of study.
  • History of non-diabetic renal disease according to investigator's opinion and/or renal transplant recipients.
  • Hyperkalaemia (K+ > 5.0 mM) at visit 1 and until randomization.
  • Clinical signs of acute or chronic urinary tract infection 14 days before randomization (based on investigator's judgement).
  • Acute febrile diseases 14 days before randomisation (based on investigator´s judgement).
  • Heart failure, patients with NYHA III / IV.
  • Surgery or trauma with significant blood loss or blood donation within 12 weeks prior to first administration of study medication (based on investigator´s judgement) or planned surgeries during the trial e.g. hip replacement (based on investigator's judgement).
  • Any other medical condition that in the investigator's opinion poses a safety risk for the patient or may interfere with the study objectives.
  • Any laboratory value more than 3 times above upper limit normal (ULN) at screening (visit 1) or any other laboratory value outside the reference range and clinically relevant in the investigator's judgment.
  • 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).
  • Previous enrolment in this trial.
  • Currently enrolled in another investigational device or drug study, or 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 patient or unlikely to complete the trial.
  • Women of childbearing potential
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03165240

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

Locations
Denmark
Steno Diabetes Center, Den Kliniske Forskningsenhed Not yet recruiting
Gentofte, Denmark, DK-2820
Nordsjællands Hospital - Hillerød Not yet recruiting
Hillerød, Denmark, 3400
Kolding Sygehus Not yet recruiting
Kolding, Denmark, DK-6000
Bispebjerg Hospital Not yet recruiting
København NV, Denmark, 2400
Rigshospitalet, København Not yet recruiting
København Ø, Denmark, 2100
Contact: Bo Feldt Rasmussen    +45 35452135    bo.feldt-rasmussen@regionh.dk   
Germany
Universitätsklinikum Carl Gustav Carus, Dresden Not yet recruiting
Dresden, Germany, 01307
InnoDiab Forschung GmbH Not yet recruiting
Essen, Germany, 45136
Universitätsklinikum Freiburg Not yet recruiting
Freiburg, Germany, 79106
Inamed GmbH Not yet recruiting
Gauting, Germany, 82131
Contact: Bärbel Huber    +49 (89) 893569533    b.huber@inamed-cro.com   
Universitätsklinikum des Saarlandes Not yet recruiting
Homburg, Germany, 66421
Institut für Diabetesforschung Münster GmbH Not yet recruiting
Münster, Germany, 48145
Contact: Ludger Rose    +49 (251) 9352300    l.rose@diabetes-muenster.de   
Universitätsklinikum Regensburg Not yet recruiting
Regensburg, Germany, 93053
Greece
University General Hospital of Ioannina Not yet recruiting
Ioannina, Greece, 45500
Contact: Moses Elisaf    +302651007509    melisaf54@gmail.com   
Iatriko of Athens Group/ Iatriko of P. Faliro Not yet recruiting
P. Faliro, Greece, 17562
Contact: John Doupis    +30 2109892300    john.doupis@joslin.harvard.edu   
Iatriko Psychikou Not yet recruiting
Psychiko, Greece, 11525
Contact: Gerasimos Karousos    +302106974281    gkarousosmd@gmail.com   
University General Hospital of Thessaloniki AHEPA Not yet recruiting
Thessaloniki, Greece, 54636
Contact: Triantafyllos Didangelos    00302310994776    didang@med.auth.gr   
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) Not yet recruiting
Bergamo, Italy, 24127
A.O. Spedali Civili di Brescia Not yet recruiting
Brescia, Italy, 25123
Fondazione IRCCS Policlinico S. Matteo Not yet recruiting
Pavia, Italy, 27100
Norway
Akershus Universitetssykehus HF Not yet recruiting
Lørenskog, Norway, N-1478
Contact: My Svensson    02900    m.h.s.svensson@medisin.uio.no   
Sponsors and Collaborators
Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03165240     History of Changes
Other Study ID Numbers: 1378-0008
2017-000563-32 ( EudraCT Number )
Study First Received: May 23, 2017
Last Updated: May 23, 2017

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

Additional relevant MeSH terms:
Eplerenone
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on May 24, 2017