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

NCT ID: NCT03165240

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-05
• Study Completion Date: 2020-05-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 690517 Dose 1

Group Type: EXPERIMENTAL

BI 690517

Intervention Type: DRUG

Film-coated tablet

BI 690517 Dose 2

Group Type: EXPERIMENTAL

BI 690517

Intervention Type: DRUG

Film-coated tablet

BI 690517 Dose 3

Group Type: EXPERIMENTAL

BI 690517

Intervention Type: DRUG

Film-coated tablet

Eplerenone

Group Type: EXPERIMENTAL

Eplerenone

Intervention Type: DRUG

Film-coated tablet

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Film-coated tablet

Interventions

BI 690517

Film-coated tablet

Intervention Type: DRUG

Eplerenone

Film-coated tablet

Intervention Type: DRUG

Placebo

Film-coated tablet

Intervention Type: DRUG

Other Intervention Names

Vicadrostat

Eligibility 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 < 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Steno Diabetes Center Copenhagen

Gentofte Municipality, , Denmark

Kolding Sygehus

Kolding, , Denmark

Bispebjerg og Frederiksberg Hospital

København NV, , Denmark

Copenhagen University Hospital, Rigshospitalet

København Ø, , Denmark

HOP d'Angers

Angers, , France

HOP Michallon

La Tronche, , France

HOP Bichat

Paris, , France

HOP la Milétrie

Poitiers, , France

HOP Nord Laënnec

Saint-Herblain, , France

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

InnoDiab Forschung GmbH

Essen, , Germany

Inamed GmbH

Gauting, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Univ. Gen. Hosp. of Ioannina

Ioannina, , Greece

Iatriko of Athens Group/ Iatriko of P. Faliro

P. Faliro, , Greece

Iatriko Psychikou

Psychikó, , Greece

University General Hospital of Thessaloniki AHEPA

Thessaloniki, , Greece

Hospital Dr. Nélio Mendonça

Funchal, , Portugal

APDP - Associação Protectora dos Diabéticos de Portugal

Lisbon, , Portugal

CHULN, EPE - Hospital de Santa Maria

Lisbon, , Portugal

Hospital Beatriz Ângelo

Loures, , Portugal

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

Porto, , Portugal

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

Kemerovo, , Russia

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

Moscow, , Russia

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

Moscow, , Russia

Baltic Med,LLC Clinic BaltMed Ozerki

Saint Petersburg, , Russia

D & R s.r.o.

Košice, , Slovakia

Hospital A Coruña

A Coruña, , Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital de Bellvitge

L'Hospitalet de Llobregat, , Spain

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Hospital Puerta de Hierro

Majadahonda, , Spain

Hospital Virgen Macarena

Seville, , Spain

Hospital Clínico de Valencia

Valencia, , Spain

CTC Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Sjukhuset, Härnösand

Härnösand, , Sweden

Universitetssjukhuset, Örebro

Örebro, , Sweden

CTC Clinical Trial Consultants AB

Uppsala, , Sweden

University Hospital of Wales

Cardiff, , United Kingdom

Countries

Denmark; France; Germany; Greece; Portugal; Russia; Slovakia; Spain; Sweden; United Kingdom

Other Identifiers

2017-000563-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1378-0008

Identifier Type: -

Identifier Source: org_study_id