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

NCT03165240 | Completed Phase 1

• 2 other identifiers: 1378-00082017-000563-32
• Study Type: interventional
• Target: 62
• Locations: 10 countries
• Sites: 40

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 \[UACR\].

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with drug related Adverse Events (AEs)

  Up to 35 days

Secondary Outcomes (2)

• 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

Study Arms (5)

BI 690517 Dose 1

EXPERIMENTAL

Drug: BI 690517

BI 690517 Dose 2

EXPERIMENTAL

Drug: BI 690517

BI 690517 Dose 3

EXPERIMENTAL

Drug: BI 690517

Eplerenone

EXPERIMENTAL

Drug: Eplerenone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 690517 DRUG

Film-coated tablet

Also known as: Vicadrostat

BI 690517 Dose 1; BI 690517 Dose 2; BI 690517 Dose 3

Eplerenone DRUG

Film-coated tablet

Eplerenone

Placebo DRUG

Film-coated tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (40)

Steno Diabetes Center Copenhagen

Gentofte Municipality, DK-2820, Denmark

Location

Kolding Sygehus

Kolding, DK-6000, Denmark

Location

Bispebjerg og Frederiksberg Hospital

København NV, 2400, Denmark

Location

Copenhagen University Hospital, Rigshospitalet

København Ø, 2100, Denmark

Location

HOP d'Angers

Angers, 49933, France

Location

HOP Michallon

La Tronche, 38700, France

Location

HOP Bichat

Paris, 75018, France

Location

HOP la Milétrie

Poitiers, 86021, France

Location

HOP Nord Laënnec

Saint-Herblain, 44800, France

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

InnoDiab Forschung GmbH

Essen, 45136, Germany

Location

Inamed GmbH

Gauting, 82131, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Profil Institut für Stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

Univ. Gen. Hosp. of Ioannina

Ioannina, 45500, Greece

Location

Iatriko of Athens Group/ Iatriko of P. Faliro

P. Faliro, 17562, Greece

Location

Iatriko Psychikou

Psychikó, 11525, Greece

Location

University General Hospital of Thessaloniki AHEPA

Thessaloniki, 54636, Greece

Location

Hospital Dr. Nélio Mendonça

Funchal, 9004-514, Portugal

Location

APDP - Associação Protectora dos Diabéticos de Portugal

Lisbon, 1250-189, Portugal

Location

CHULN, EPE - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospital Beatriz Ângelo

Loures, 2674-514, Portugal

Location

Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António

Porto, 4099-001, Portugal

Location

Res.Inst.-Compl.Iss.Cardi.Dis.

Kemerovo, 650002, Russia

Location

City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow

Moscow, 109263, Russia

Location

Nonstate Private Healthcare Institution "Scientific Clinical Center of LLC Russian Railways"

Moscow, 125315, Russia

Location

Baltic Med,LLC Clinic BaltMed Ozerki

Saint Petersburg, 194356, Russia

Location

D & R s.r.o.

Košice, 040 22, Slovakia

Location

Hospital A Coruña

A Coruña, 15006, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Puerta de Hierro

Majadahonda, 28222, Spain

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

Hospital Clínico de Valencia

Valencia, 46010, Spain

Location

CTC Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

Location

Sjukhuset, Härnösand

Härnösand, 871 31, Sweden

Location

Universitetssjukhuset, Örebro

Örebro, 701 85, Sweden

Location

CTC Clinical Trial Consultants AB

Uppsala, 75237, Sweden

Location

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 24, 2017
• Study Start: October 5, 2017
• Primary Completion: April 16, 2020
• Study Completion: May 7, 2020
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

DK (4); GR (4); SE (4); RU (4); PT (5); FR (5); SL (1); GB (1); DE (5); ES (7)