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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03165240
Other study ID # 1378-0008
Secondary ID 2017-000563-32
Status Completed
Phase Phase 1
First received
Last updated
Start date October 5, 2017
Est. completion date May 7, 2020

Study information

Verified date September 2020
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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].


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date May 7, 2020
Est. primary completion date April 16, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

- Further exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BI 690517
Film-coated tablet
Eplerenone
Film-coated tablet
Placebo
Film-coated tablet

Locations

Country Name City State
Denmark Steno Diabetes Center Copenhagen Gentofte
Denmark Bispebjerg og Frederiksberg Hospital København NV
Denmark Copenhagen University Hospital, Rigshospitalet København Ø
Denmark Kolding Sygehus Kolding
France HOP d'Angers Angers
France HOP Michallon La Tronche
France HOP Bichat Paris
France HOP la Milétrie Poitiers
France HOP Nord Laënnec Saint-Herblain
Germany Universitätsklinikum Carl Gustav Carus Dresden Dresden
Germany InnoDiab Forschung GmbH Essen
Germany Inamed GmbH Gauting
Germany Medizinische Hochschule Hannover Hannover
Germany Profil Institut für Stoffwechselforschung GmbH Neuss
Greece Univ. Gen. Hosp. of Ioannina Ioannina
Greece Iatriko of Athens Group/ Iatriko of P. Faliro P. Faliro
Greece Iatriko Psychikou Psychiko
Greece University General Hospital of Thessaloniki AHEPA Thessaloniki
Portugal Hospital Dr. Nélio Mendonça Funchal
Portugal APDP - Associação Protectora dos Diabéticos de Portugal Lisboa
Portugal CHULN, EPE - Hospital de Santa Maria Lisboa
Portugal Hospital Beatriz Ângelo Loures
Portugal Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António Porto
Russian Federation 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 Nonstate Private Healthcare Institution "Scientific Clinical Center of LLC Russian Railways" Moscow
Russian Federation Baltic Med,LLC Clinic BaltMed Ozerki St. Petersburg
Slovakia D & R s.r.o. Kosice
Spain 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 Sevilla
Spain Hospital Clínico de Valencia Valencia
Sweden CTC Sahlgrenska Universitetssjukhuset Göteborg
Sweden Sjukhuset, Härnösand Härnösand
Sweden Universitetssjukhuset, Örebro Örebro
Sweden CTC Clinical Trial Consultants AB Uppsala
United Kingdom University Hospital of Wales Cardiff

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Greece,  Portugal,  Russian Federation,  Slovakia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with drug related Adverse Events (AEs) Up to 35 days
Secondary Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in morning void urine Up to 28 days
Secondary Change from baseline in log transformed Urine Albumin-to-Creatinine Ratio (UACR) measured in daytime (10-hour) urine Up to 28 days
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