Clinical trial • Phase II • Endocrinology | Nephrology

BI 690517 for Chronic kidney disease

Phase II trial of BI 690517 for Chronic kidney disease.

Overview

Trial Therapeutic Area
Endocrinology | Nephrology
Trial Disease
Chronic kidney disease
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-04-2025
First CTIS Authorization Date
04-08-2025

Trial design

Randomised, simultaneous initiation of vicadrostat (bi 690517) + empagliflozin (jardiance 10 mg film-coated tablets) versus staggered initiation of vicadrostat and empagliflozin; placebo matching vicadrostat is used for blinding. (doses specified for empagliflozin: jardiance 10 mg film-coated tablets. bi 690517 dosing not specified in provided data.)-controlled Phase II trial across 40 sites in Spain, Belgium, Czechia and others.

Randomised
Yes
Comparator
Simultaneous initiation of vicadrostat (BI 690517) + empagliflozin (Jardiance 10 mg film-coated tablets) versus staggered initiation of vicadrostat and empagliflozin; placebo matching vicadrostat is used for blinding. (Doses specified for empagliflozin: Jardiance 10 mg film-coated tablets. BI 690517 dosing not specified in provided data.)
Target Sample Size
316

Eligibility

Recruits 316 No vulnerable populations selected. Participants must be at least 18 years old (and at least the legal age of consent where higher) and provide signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. No assent procedures (minors are excluded)..

Vulnerable Population
No vulnerable populations selected. Participants must be at least 18 years old (and at least the legal age of consent where higher) and provide signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. No assent procedures (minors are excluded).

Inclusion criteria

  • {"criterion_text":"-At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years.\n-Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n-Male or female participants. WOCBP must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. For men, birth control is not required during the trial.\n-Evidence of CKD at risk of progression based on two eGFR measurements recorded recently (i.e. within 1 year) and at the time of Visit 1, with each eGFR ≥20 and <60 mL/min/1.73m2, irrespective of UACR. The first of these measurements will be assessed from historical local laboratory results, and the second will be determined from serum creatinine analysed by the central laboratory at Visit 1\n-Treatment with a clinically appropriate, stable dose of either ACEi or ARB (but not both together) for ≥4 weeks before Visit 1, with no planned changes of the therapy for the duration of the trial"}

Exclusion criteria

  • {"criterion_text":"-Treatment with an SGLT2i within 4 weeks before Visit 2. Treatment with an SGLT2i should not be interrupted with the intention of enrolment into the trial.\n-Treatment with an MRA, ASi, or potassium-sparing diuretic(s) within 14 days prior to Visit 1, or requiring such treatment before randomisation, or planned during the trial, based on the judgment of the investigator. Treatment with an MRA or ASi should not be interrupted with the intention of enrolment into the trial.\n-Blood potassium of >5.2 mmol/L measured by the central laboratory at Visit 1. (Note: One reassessment of serum potassium is allowed during screening)\n-Blood ALT or AST >3x ULN at Visit 1.\n-Known severe hepatic impairment (i.e. Child Pugh class C cirrhosis).\n-On dialysis, functioning kidney transplant, or scheduled for transplant.\n-Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days.\n-Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone).\n-Further exclusion criteria apply."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Absolute change in eGFR (mL/min/1.73m2) from baseline to Week 14 and week 16","definition_or_measurement_approach":"Absolute change in eGFR (mL/min/1.73m2) from baseline to Week 14 and Week 16; baseline eGFR determined from serum creatinine analysed by the central laboratory at Visit 1."}

Secondary endpoints

  • {"endpoint_text":"-Absolute change in eGFR (mL/min/1.73m2) from baseline to Week 12","definition_or_measurement_approach":"Absolute change in eGFR (mL/min/1.73m2) from baseline to Week 12; eGFR based on serum creatinine measurements."}
  • {"endpoint_text":"-Absolute change in SBP (mmHg) from baseline to Week 12","definition_or_measurement_approach":"Absolute change in systolic blood pressure (mmHg) from baseline to Week 12; measured in clinic per protocol."}
  • {"endpoint_text":"-Relative change (ratio) in UACR from baseline to Week 6","definition_or_measurement_approach":"Relative change (ratio) in urine albumin creatinine ratio (UACR) from baseline to Week 6; UACR measured in urine samples."}
  • {"endpoint_text":"-Absolute change in serum potassium (mmol/L) from baseline to Week 12","definition_or_measurement_approach":"Absolute change in serum potassium (mmol/L) from baseline to Week 12; serum potassium measured (central laboratory measurement at Visit 1 is specified for baseline)."}

Recruitment

Registry Or Advocacy Recruitment
True, Treant Ziekenhuiszorg Stichting | Amsterdam UMC Stichting (patient organisations listed as trial sites) and study-listing/registry materials referenced (e.g. Czech and Polish 'study-listing-registry' recruitment materials).
Digital Remote Recruitment
True, digital/remote methods include website materials, Google Ads, website pre-login and post-login content, online patient videos and video scripts, and other online recruitment materials (country-specific versions exist, e.g. DE, NL, BE).
Planned Sample Size
316
Recruitment Window Months
17
Consent Approach
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Participants provide consent themselves (minimum age 18). Informed consent forms and subject information available in multiple country/language versions (examples in ES, BE, FR, DE, IT, NL, PL, CZ, EN). Re-consent materials are provided where applicable.

Methods

  • Clinic wall posters (country-specific materials available: ES, BE, DE, IT, NL, PL, CZ).
  • Patient information brochures and patient-facing leaflets (country-specific translations: ES, BE, FR, DE, IT, NL, PL, CZ).
  • Video scripts / patient videos and MOA scripts for use in patient-facing recruitment (country-specific).
  • Website materials and online ads (including pre-login and post-login website content and Google Ads – e.g. DE materials indicate website and Google Ads).
  • GP/physician referral letters and clinic referral materials (examples present in IT materials).
  • Simple show/explanatory materials (simpleshow scripts) and clinic materials for use in primary care settings.

Geography

Total Number Of Sites
40
Total Number Of Participants
100

Spain

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
238
Number Of Sites
6
Number Of Participants
16

Sites

Site Name
Centro de Salud Cartagena Casco Antiguo
Department Name
Atención primaria
Contact Person Name
Ana Cebrián Cuenca
Contact Person Email
anicebrian@gmail.com
Site Name
Centro de Salud Milladoiro
Department Name
Medicina Familiar y Comunitaria
Contact Person Name
Sergio Cinza Sanjurjo
Contact Person Email
scinzas@semergen.es
Site Name
Equip D'Atencio Primaria Barcelona Sardenya S.L.P.
Department Name
Atención Primaria
Contact Person Name
Carlen Reyes
Contact Person Email
creyes@eapsardenya.cat
Site Name
Centro de Salud San Juanb
Department Name
Atencion Primaria
Contact Person Name
Emiliano Rodríguez Sánchez
Contact Person Email
emiliano@usal.es
Site Name
Centro de Salud Naranco
Department Name
Medicina Familiar y Comunitaria
Contact Person Name
Ana María Piera Carbonell
Contact Person Email
apiecar@gmail.com
Site Name
Eap Osona Sud Alt Congost S.L.P.
Department Name
Medicina Familiar y Comunitaria
Contact Person Name
Silvia Narejos Pérez
Contact Person Email
snarejos@ebacentelles.cat

Belgium

Earliest CTIS Part Ii Submission Date
04-07-2025
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
210
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Nephrology department
Contact Person Name
Nathalie Demoulin
Site Name
Hopital Erasme
Department Name
Nephrology department
Contact Person Name
Caroline La
Contact Person Email
caroline.la@hubruxelles.be
Site Name
HUmani
Department Name
Néphrologie
Contact Person Name
Nathan Neveux
Contact Person Email
nathan.neveux@humani.be
Site Name
UZ Leuven
Department Name
Nephrology department
Contact Person Name
Amaryllis Van Craenenbroeck

Czechia

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
204
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Nemocnice Slany
Department Name
Internal Department
Contact Person Name
Matej Falc
Contact Person Email
matej.falc@nemsl.cz
Site Name
Milan Kvapil s.r.o.
Department Name
Diabetology and internal medicine clinic Ravak
Contact Person Name
Dagmar Bartaskova
Contact Person Email
dagmar.bartaskova@centrum.cz
Site Name
Dum zdravi Havirov s.r.o.
Department Name
Private practice
Contact Person Name
Marian Pirchala
Contact Person Email
pirchala@seznam.cz

France

Earliest CTIS Part Ii Submission Date
14-07-2025
Latest Decision Or Authorization Date
29-01-2026
Processing Time Days
199
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Bicetre Hospital
Department Name
Service de Néphrologie et Transplantation rénale
Contact Person Name
Renaud Snanoudj
Contact Person Email
renaud.snanoudj@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service de Néphrologie - Transplantation
Contact Person Name
Jacques Dantal
Contact Person Email
jacques.dantal@chu-nantes.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Néphrologie, Dialyse et Transplantation Rénale
Contact Person Name
Nans Florens

Germany

Earliest CTIS Part Ii Submission Date
24-07-2025
Latest Decision Or Authorization Date
30-01-2026
Processing Time Days
190
Number Of Sites
12
Number Of Participants
29

Sites

Site Name
Klinikum Bielefeld gGmbH
Department Name
Universitätsklinik für Endokrinologie und Diabetologie, Allgemeine Innere Medizin, Infektiologie
Contact Person Name
Joachim Feldkamp
Site Name
Goethe University Frankfurt
Department Name
Else Kröner-Fresenius-Zentrum für Nephrologische Forschung
Contact Person Name
Jeannine Lang
Site Name
Gemeinschaftspraxis Hamann/Bacčinović/Jacobsen, Dialysezentrum Rotenburg
Department Name
Nierenheilkunde und Bluthochdruckkrankheiten
Contact Person Name
Mustafa Bacinovic
Contact Person Email
bacinovic@dialyse-walsrode.de
Site Name
Medizinische Hochschule Hannover
Department Name
Studienzentrum für Nieren- und Hochdruckerkrankungen
Contact Person Name
Jessica Kaufeld
Contact Person Email
kaufeld.jessica@mh-hannover.de
Site Name
Studiengesellschaft Drs Könemann / Steinmann
Department Name
Diabetologische Schwerpunktpraxis
Contact Person Name
Kai Könemann
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
der Technischen Universität Dresden, Med. Klinik und Poliklinik III
Contact Person Name
Christian Hugo
Site Name
MVZ DaVita Geilenkirchen GmbH
Department Name
DaVita Düsseldorf
Contact Person Name
Thilo Krüger
Contact Person Email
thilo.krueger@davita.com
Site Name
Synexus Clinical Research GmbH
Department Name
Prüfzentrum Leipzig
Contact Person Name
Katrin Arelin
Contact Person Email
katrin.arelin@globalaes.com
Site Name
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department Name
Allgemeine Innere Medizin und Nephrologie
Contact Person Name
Jörg Latus
Contact Person Email
joerg.latus@rbk.de
Site Name
Zentrum Fuer Nieren Hochdruck Und Stoffwechselerkrankungen
Department Name
Dialysis Hannover
Contact Person Name
Georg Schlieper
Site Name
Synexus Clinical Research GmbH (Frankfurt site)
Department Name
Prüfzentrum Frankfurt
Contact Person Name
Nathalie Spohner
Contact Person Email
Nathalie.spohner@globalaes.com
Site Name
Synexus Clinical Research GmbH (Berlin site)
Department Name
Prüfzentrum Berlin
Contact Person Name
Agata Malkiewicz
Contact Person Email
agata.malkiewicz@globalaes.com

Italy

Earliest CTIS Part Ii Submission Date
25-07-2025
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
230
Number Of Sites
4
Number Of Participants
13

Sites

Site Name
Istituto Di Ricerche Farmacologiche Mario Negri
Department Name
Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò dell'Istituto Mario Negri
Contact Person Name
Aneliya Parvanova
Site Name
Universita' Degli Studi Di Perugia
Department Name
Dipartimento di medicina e chirurgia
Contact Person Name
Gianpaolo Reboldi
Contact Person Email
paolo.reboldi@unipg.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Nefrologia
Contact Person Name
Giuseppe Grandaliano
Site Name
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Department Name
Clinica Nefrologica
Contact Person Name
Mario Bonomini
Contact Person Email
mario.bonomini@unich.it

Netherlands

Earliest CTIS Part Ii Submission Date
25-07-2025
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
196
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Albert Schweitzer Ziekenhuis
Department Name
Department of Internal Medicine
Contact Person Name
Jeroen Van Der Net
Contact Person Email
j.b.vandernet@asz.nl
Site Name
Treant Ziekenhuiszorg Stichting
Department Name
Department of internal medicine
Contact Person Name
Adriaan Kooy
Contact Person Email
a.kooy@treant.nl
Site Name
Amsterdam UMC Stichting
Department Name
Department of Internal Medicine
Contact Person Name
Liffert Vogt
Contact Person Email
l.vogt@amsterdamumc.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
Nefrologie
Contact Person Name
Stijn Konings

Poland

Earliest CTIS Part Ii Submission Date
18-07-2025
Latest Decision Or Authorization Date
08-02-2026
Processing Time Days
205
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Pro Familia Altera Sp. z o.o.
Department Name
Private Practice
Contact Person Name
Danuta Wronska
Site Name
Centrum Medyczne "Hipokrates" S.C. Elżbieta i Grzegorz Grześk
Department Name
Private Practice
Contact Person Name
Grzegorz Grzesk
Contact Person Email
grzegorz.grzesk@interia.pl
Site Name
American Heart Of Poland S.A.
Department Name
Malopolska Cardiovascular Centre, PAKS
Contact Person Name
Aleksander Zurakowski
Contact Person Email
olekzurakowski@gmail.com
Site Name
Pro Salus Sp. z o.o. sp.k.
Department Name
Private Practice
Contact Person Name
Marcin Ojrzanowski
Contact Person Email
ojrzan@o2.pl

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Co-sponsors

  • Boehringer Ingelheim Espana S.A.

Investigational products

Investigational Product Name
BI 690517
Active Substance
BI 690517
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus 1
Investigational Product Name
Jardiance 10 mg film-coated tablets
Active Substance
Empagliflozin
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Marketing authorisation: EU/1/14/930/018
Starting Dose
10 mg
Investigational Product Name
Placebo matching vicadrostat
Modality
Other
Combination Treatment
Yes

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