This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated
- Conditions
- Diabetic Nephropathies
- Interventions
- Registration Number
- NCT03165240
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this current trial is to investigate the safety and tolerability of 3 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 \[UACR\].
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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 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.
- Treatment with with SGLT2 inhibitors and/or inhibitors of aldosterone mediated effects like mineralocorticoid receptor antagonists at visit 1 and thereafter.
- Intake of potassium sparing diuretics like amiloride or potassium supplements during the study (this period starts at Visit 1).
- At Visit 1 cortisol peak level 30 minutes (± 5 min) after iv injection of Adrenocorticotropic hormone (ACTH) is an increase by less than 200 nmol/l compared to pre-ACTH injection.
- 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 mmol/L) at visit 1 and until start of treatment measured by any local or central lab.
- 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
- Further exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BI 690517 Dose 1 BI 690517 - BI 690517 Dose 2 BI 690517 - BI 690517 Dose 3 BI 690517 - Eplerenone Eplerenone - Placebo Placebo -
- 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-to-Creatinine Ratio (UACR) measured in morning void urine Up to 28 days Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in daytime (10-hour) urine Up to 28 days
Trial Locations
- Locations (40)
Steno Diabetes Center Copenhagen
🇩🇰Gentofte, Denmark
Bispebjerg og Frederiksberg Hospital
🇩🇰København NV, Denmark
Copenhagen University Hospital, Rigshospitalet
🇩🇰København Ø, Denmark
HOP d'Angers
🇫🇷Angers, France
Hospital Dr. Nélio Mendonça
🇵🇹Funchal, Portugal
University General Hospital of Thessaloniki AHEPA
🇬🇷Thessaloniki, Greece
Iatriko Psychikou
🇬🇷Psychiko, Greece
Inamed GmbH
🇩🇪Gauting, Germany
HOP la Milétrie
🇫🇷Poitiers, France
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
APDP - Associação Protectora dos Diabéticos de Portugal
🇵🇹Lisboa, Portugal
Iatriko of Athens Group/ Iatriko of P. Faliro
🇬🇷P. Faliro, Greece
Profil Institut für Stoffwechselforschung GmbH
🇩🇪Neuss, Germany
Univ. Gen. Hosp. of Ioannina
🇬🇷Ioannina, Greece
Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António
🇵🇹Porto, Portugal
Hospital Puerta de Hierro
🇪🇸Majadahonda, Spain
Hospital A Coruña
🇪🇸A Coruña, Spain
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Beatriz Ângelo
🇵🇹Loures, Portugal
D & R s.r.o.
🇸🇰Kosice, Slovakia
Nonstate Private Healthcare Institution "Scientific Clinical Center of LLC Russian Railways"
🇷🇺Moscow, Russian Federation
Baltic Med,LLC Clinic BaltMed Ozerki
🇷🇺St. Petersburg, Russian Federation
Sjukhuset, Härnösand
🇸🇪Härnösand, Sweden
CTC Clinical Trial Consultants AB
🇸🇪Uppsala, Sweden
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
HOP Bichat
🇫🇷Paris, France
HOP Michallon
🇫🇷La Tronche, France
HOP Nord Laënnec
🇫🇷Saint-Herblain, France
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Kolding Sygehus
🇩🇰Kolding, Denmark
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
CHULN, EPE - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Res.Inst.-Compl.Iss.Cardi.Dis.
🇷🇺Kemerovo, Russian Federation
City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow
🇷🇺Moscow, Russian Federation
Universitetssjukhuset, Örebro
🇸🇪Örebro, Sweden
Hospital de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
CTC Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
Hospital Clínico de Valencia
🇪🇸Valencia, Spain