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A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05182840
Collaborator
(none)
552
Enrollment
176
Locations
4
Arms
17.7
Anticipated Duration (Months)
3.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study.

The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin.

In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine.

In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine.

Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call.

Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Condition or Disease Intervention/Treatment Phase
  • Drug: BI 690517
  • Drug: Placebo to BI 690517
  • Drug: Empagliflozin
  • Drug: Placebo to empagliflozin
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
552 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomised, Double-blind, Placebo-controlled and Parallel Dose Group Trial to Investigate Efficacy and Safety of Multiple Doses of Oral BI 690517 Over 14 Weeks, Alone and in Combination With Empagliflozin, in Patients With Diabetic and Non-diabetic Chronic Kidney Disease
Actual Study Start Date :
Jan 11, 2022
Anticipated Primary Completion Date :
Jun 6, 2023
Anticipated Study Completion Date :
Jul 4, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment period: Empagliflozin + BI 690517

Drug: BI 690517
BI 690517

Drug: Empagliflozin
Empagliflozin
Experimental: Treatment period: Empagliflozin + Placebo to BI 690517

Drug: Placebo to BI 690517
Placebo to BI 690517

Drug: Empagliflozin
Empagliflozin
Experimental: Treatment period: Placebo to Empagliflozin + BI 690517

Drug: BI 690517
BI 690517
Placebo Comparator: Treatment period: Placebo to Empagliflozin + Placebo to BI 690517

Drug: Placebo to BI 690517
Placebo to BI 690517

Drug: Placebo to empagliflozin
Placebo to empagliflozin

Outcome Measures

Primary Outcome Measures

  1. Change from treatment period baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine [up to 14 weeks]

Secondary Outcome Measures

  1. UACR response I, defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline [up to 14 weeks]

  2. UACR response II, defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline [up to 14 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion criteria

  • Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

  • Male or female patients of legal adult age (according to local legislation) and aged ≥ 18 years at time of consent.

  • estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 30 and < 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis.

  • Urine Albumin Creatinine Ratio (UACR) ≥ 200 and < 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.1

  • If the patient is taking any of the following medications they should be on a stable dose for at least 4 weeks prior to visit 1 and until first randomisation prior to run-in with no planned change of the therapy during the trial: anti-hypertensives, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), endothelin receptor antagonists, low dose systemic steroids (e.g. prednisolone ≤10 mg or equivalent).

  • Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for ≥ 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial.

  • In the Investigator's opinion, any kind of diagnosed chronic kidney disease (Diagnosis can be reached by standard clinical method, no biopsy required). Patients with diabetic kidney disease must have type 2 diabetes mellitus and their treatment (including GLP1 receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation.

  • Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1 measured by the central laboratory.

  • Serum potassium ≤ 4.8 mmol/L at Visit 1 measured by the central laboratory.

  • Seated Systolic Blood Pressure (SBP) ≥ 110 and ≤ 160 mmHg and Diastolic Blood Pressure (DBP) ≥ 65 and ≤ 110 mmHg at Visit 1 (mean values from three Blood Pressure (BP) measurements) and optimised anti-hypertensive treatment according to local standard of care and investigator's judgement.

  • Body Mass Index (BMI) ≥ 18.5 and < 50 kg/m2 at Visit 1.

  • Women of child-bearing potential2 (WOCBP) must be ready and able to use highly effective methods of birth control. Such methods should be used throughout the trial. Men must be vasectomised or willing and able to use a condom if their partner is a WOCBP.

Additional inclusion criteria to be assessed before second randomisation (start of

Treatment Period):

  • Serum potassium ≤ 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.

  • eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥ 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.

Exclusion criteria

  • Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase.

  • Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial are also excluded.

  • Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA))

  • Patients at increased risk of ketoacidosis in the opinion of the investigator.

  • Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial.

Further criteria apply.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aventiv Research Inc. Mesa Arizona United States 85206
2 AKDHC Medical Research Services, LLC Phoenix Arizona United States 85027
3 Clearview Medical Research, LLC Canyon Country California United States 91351
4 Pacific Renal Associates Long Beach California United States 90806
5 Valley Clinical Trials, Inc. Northridge California United States 91325
6 Apex Research of Riverside Riverside California United States 92505
7 California Kidney Specialists San Dimas California United States 91773
8 Clinical Research of Brandon LLC Brandon Florida United States 33511
9 Horizon Research Group Coral Gables Florida United States 33134
10 Elixia Fort Lauderdale, LLC Fort Lauderdale Florida United States 33308
11 South Florida Research Institute Lauderdale Lakes Florida United States 33313
12 San Marcus Research Clinic, Inc. Miami Florida United States 33014
13 Total Research Group, LLC Miami Florida United States 33126
14 Horizon Research Group, LLC Miami Florida United States 33150
15 West Orange Endocrinology Ocoee Florida United States 34761
16 Pines Care Research Center Pembroke Pines Florida United States 33024
17 Elixia Tampa, LLC Temple Terrace Florida United States 33637
18 Boise Kidney and Hypertension PLLC Nampa Idaho United States 83687
19 Cedar Crosse Research Center Chicago Illinois United States 60607
20 Kansas Nephrology Research Institute, LLC Wichita Kansas United States 67214
21 Aa Mrc Llc Flint Michigan United States 48504
22 Elite Research Center, LLC Flint Michigan United States 48532
23 Clinical Research Consultants, LLC Kansas City Missouri United States 64111
24 Forte Family Practice Las Vegas Nevada United States 89103
25 Seacoast Kidney and Hypertension Specialists Portsmouth New Hampshire United States 03801
26 New Mexico Clinical Research and Osteoporosis Center, Inc. Albuquerque New Mexico United States 87106
27 Randolph Health Internal Medicine Asheboro North Carolina United States 27203
28 Lucas Research, Inc. Morehead City North Carolina United States 28557
29 Diabetes & Endocrinology Associates of Stark County Canton Ohio United States 44718
30 Heritage Valley Medical Group Beaver Pennsylvania United States 15009
31 Elixia Upland, LLC Upland Pennsylvania United States 19013
32 Monument Health Rapid City South Dakota United States 57701
33 Research Institute of Dallas Dallas Texas United States 75231
34 Academy Of Diabetes, Thyroid And Endocrine, PA El Paso Texas United States 79935
35 PrimeCare Medical Group Houston Texas United States 77024
36 P&I Clinical Research, LLC Lufkin Texas United States 75904
37 Simcare Medical Research, LLC Sugar Land Texas United States 77478
38 Providence Medical Research Center Spokane Washington United States 99204
39 Universal Research Group, LLC Tacoma Washington United States 98405
40 CIMEL centro de Investigaciones Médicas Lanús Buenos Aires Argentina B1824KAJ
41 CEDIC - Centro de Investigacion Clinica Caba Argentina C1060ABN
42 Glenny Corp. S.A. Bioclinica Argentina Ciudad Autonoma Buenos Aires Argentina C1430CKE
43 Centro de Salud Renal Junín Junín Argentina B6000GMA
44 Centro de Investigaciones Médicas Mar del Plata Argentina B7600FYK
45 CEMEDIC - Centro de Especialidades Medicas Villa Luro Argentina C1440CFD
46 John Hunter Hospital New Lambton Heights New South Wales Australia 2305
47 Monash University Box Hill Victoria Australia 3128
48 St Vincent's Hospital Melbourne Fitzroy Victoria Australia 3065
49 Bonheiden - HOSP Imelda Bonheiden Belgium 2820
50 Brussels - UNIV UZ Brussel Brussel Belgium 1090
51 Brussels - UNIV Saint-Luc Bruxelles Belgium 1200
52 La Louvière - UNIV CHU Tivoli La Louvière Belgium 7100
53 UZ Leuven Leuven Belgium 3000
54 Liège - UNIV CHU Sart Tilman Liège Belgium 4000
55 Charleroi - UNIV CHU de Charleroi Lodelinsart Belgium 6042
56 Hospital Universitário João de Barros Barreto Belém Brazil CEP 66073-
57 Faculdade de Medicina de Botucatu - UNESP Botucatu Brazil 18618-687
58 Fundação Pró Renal Brasil Curitiba Brazil 80440-020
59 Núcleo de Pesquisa Clínica do Rio Grande do Sul Porto Alegre Brazil 90430-001
60 Hospital Regional Hans Dieter Schmidt Santa Catarina Brazil 89227
61 Centro de Pesquisa Clinica - CPCLIN Sao Paulo Brazil 01244-030
62 BR Trials Sao Paulo Brazil 05003090
63 CEMEC - Centro Multidisciplinar de Estudos Clínicos São Bernardo do Campo Brazil 09780-000
64 Multiprofile Hospital for Active Treatment Trimontsium OOD Plovdiv Bulgaria 4000
65 Medical Center Rusemed Ruse Bulgaria 7013
66 Robert Koch Clinic Sofia Sofia Bulgaria 1407
67 UMHAT "Sveti Ivan Rilski" Sofia Bulgaria 1431
68 Medical Center Synexus Sofia EOOD Sofia Bulgaria 1784
69 MHAT Prof Stoyan Kirkovich AD Stara Zagora Bulgaria 6000
70 The Bailey Clinic Red Deer Alberta Canada T4N 6V7
71 LMC Clinical Research Inc. (Brampton) Brampton Ontario Canada L6S 0C6
72 LMC Manna Research (Burlington North) Burlington Ontario Canada L7M 4Y1
73 LMC Clinical Research Inc. (Etobicoke) Etobicoke Ontario Canada M9R 4E1
74 Recherche GCP Research Montreal Quebec Canada H1M 1B1
75 Guangdong Provincial People's Hospital Guangzhou China 510080
76 Zhejiang Province People's Hospital Hangzhou China 310014
77 The First People's Hospital of Nanning Nanning China 530000
78 Shanghai Fifth People's Hospital affiliated to Fudan University Shanghai China 200240
79 DIKa centrum s.r.o. Havirov Czechia 73601
80 Aarhus University Hospital Aarhus N Denmark 8200
81 Copenhagen University Hospital, Rigshospitalet København Ø Denmark 2100
82 Satucon Oy Kuopio Finland 70100
83 Tampere University Hospital Tampere Finland 33521
84 Turku University Hospital / TYKS Turku Finland 20520
85 Institut für klinische Forschung und Entwicklung (IKFE) Berlin GmbH Berlin Germany 10437
86 Cardiologicum Dresden und Pirna Dresden Germany 01277
87 Universitätsklinikum Carl Gustav Carus Dresden Dresden Germany 01307
88 DaVita Clinical Research Germany GmbH Düsseldorf Germany 40210
89 Synexus Clinical Research GmbH Frankfurt Germany 60313
90 Medizinische Hochschule Hannover Hannover Germany 30625
91 Synexus Clinical Research GmbH Leipzig Germany 04103
92 Universitätsklinikum Würzburg AÖR Würzburg Germany 97080
93 Iatriko of Athens Group/ Iatriko of P. Faliro P. Faliro Greece 17562
94 General Hospital of Thessaloniki "G.Papageorgiou" Thessaloniki Greece 56403
95 Prince of Wales Hospital Hong Kong Hong Kong 999077
96 Queen Mary Hospital Hong Kong Hong Kong
97 Lausmed Kft. Outpatient Unit of Internal Medicine Baja Hungary 6500
98 DRC Gyogyszervizsgalo Kozpont Kft., Balatonfured Balatonfured Hungary 8230
99 Synexus Hungary Healthcare Service Ltd. Budapest Hungary 1036
100 Semmelweis University Budapest Hungary 1083
101 University Debrecen Hospital Debrecen Hungary 4032
102 Markhot Ferenc Hospital, Eger Eger Hungary 3300
103 Synexus Hungary Healthcare Service Ltd Gyula Hungary 5700
104 BKS Research Ltd Hatvan Hungary 3000
105 Jaipur National University Institute for Medical Science & Research Centre Jaipur India 302017
106 Ganesh Shankar Vidyarthi Memorial Medical College Kanpur India 208002
107 K R Hospital Mysore Medical College and Research Centre Mysore India 570001
108 Muljibhai Patel Urological Hospital Nadiad India 387001
109 Kingsway Hospitals Nagpur India 440001
110 All India Institute of Medical Sciences New Delhi India 110029
111 Shree Giriraj Multispeciality Hospital Rajkot India 360005
112 Unity Trauma and ICU Centre (Unity Hospital) Surat India 395010
113 Galaxy Lifecare Services Pvt. Ltd. Varanasi India 221010
114 Christian Medical College Vellore India 632004
115 A.O. Policlinico Giovanni XXIII di Bari Bari Italy 70124
116 ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII Bergamo Italy 24127
117 Daiyukai Clinic Aichi, Ichinomiya Japan 491-8551
118 Meitetsu Hospital Aichi, Nagoya Japan 451-8511
119 Nagoya Kyoritsu Hospital Aichi, Nagoya Japan 454-0933
120 National Hospital Organization Takasaki General Medical Center Gumma, Takasaki Japan 370-0829
121 Kyoto Okamoto Memorial Hospital Kyoto, Kuse-gun Japan 613-0034
122 Ina Central Hospital Nagano, Ina Japan 396-8555
123 Suwa Red Cross Hospital Nagano, Suwa Japan 392-8510
124 Asano Clinic Saitama, Kawagoe Japan 350-0851
125 Omihachiman Community Medical Center Shiga, Omihachiman Japan 523-0082
126 Miho Clinic Tokyo, Shinagawa-ku Japan 141-0032
127 Yamaura Medical Clinic Ueda, Nagano Japan 386-0407
128 Chungbuk National University Hospital Cheongiu Korea, Republic of 28644
129 Inje University Ilsan Paik Hospital Goyang Korea, Republic of 10380
130 Seoul National University Hospital Seoul Korea, Republic of 03080
131 Severance Hospital Seoul Korea, Republic of 03722
132 The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul Korea, Republic of 22711
133 Hospital Selayang Batu Caves Malaysia 68100
134 University Kebangsaan Malaysia Cheras, Kuala Lumpur Malaysia 56000
135 Tuanku Fauziah Hospital Kangar Malaysia 01000
136 Hospital Raja Perempuan Zainab II, Kota Bharu Kota Bharu Malaysia 15200
137 Hospital Seri Manjung Seri Manjung Malaysia 32040
138 Centro de Investigacion Cardiometabolica de Aguascalientes Aguascalientes Mexico 20230
139 Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Mexico Mexico 20010
140 CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc México Mexico 11650
141 Helse Stavanger, Stavanger Universitetssykehus Stavanger Norway 4011
142 Norzel Medical and Diagnostic Clinic Cebu City Philippines 6000
143 Institute for Studies on Diabetes Foundation Inc. Marikina city Philippines 1810
144 The Medical City Pasig City Philippines 1605
145 INTERCORE Medical Center Bydgoszcz Poland 85-605
146 Synexus Polska Sp. Z o.o. Oddział w Czestochowie Czestochowa Poland 42202
147 Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk Gdansk Poland 80-382
148 Synexus Polska Sp. z o.o. Oddzial w Gdyni, Gdynia Gdynia Poland 81-384
149 Synexus Polska Sp. z o.o. Oddzial w Katowicach, Katowice Katowice Poland 40-040
150 Pro Familia Altera Katowice Poland 40-648
151 SOMED CR Sp. z o.o. Sp. Komandytowa Lodz Poland 90-368
152 Synexus Polska Sp. Z o.o. Oddział w Lodzi Lodz Poland 90127
153 Synexus Polska sp. z o.o. Oddzial w Poznaniu, Poznan Poznan Poland 60-702
154 Independent Health Care Center HCP Medical Center Poznan Poland 61-485
155 Synexus Polska Sp. z o.o. Oddzial w Warszawie, Warszawa Warszawa Poland 01-192
156 Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Wroclaw Wroclaw Poland 50-088
157 Hospital Garcia de Orta, EPE Almada Portugal 2801-951
158 Centro Hospitalar do Baixo Vouga - Hospital Infante Dom Pedro Aveiro Portugal 3810-164
159 CHLO, EPE - Hospital de Santa Cruz Carnaxide Portugal 2790-134
160 APDP - Associação Protectora dos Diabéticos de Portugal Lisboa Portugal 1250-189
161 Centro Hospitalar de Vila Nova de Gaia Vila Nova de Gaia Portugal 4434-502
162 Synexus Helderberg Clinical Research Centre Cape Town South Africa 7130
163 TREAD Research Cape Town South Africa 7500
164 Paarl Research Centre Cape Town South Africa 7646
165 Dr. Jurgens Krugersdorp South Africa 1739
166 Synexus Watermeyer Clinical Research Centre Pretoria South Africa 0184
167 Hospital Vall d'Hebron Barcelona Spain 08035
168 Hospital Público Da Mariña Burela Spain 27880
169 Hospital Universitario Reina Sofía Córdoba Spain 14004
170 Fundación Jiménez Díaz Madrid Spain 28040
171 Hospital Puerta de Hierro Majadahonda Spain 28222
172 Hospital de Son Llàtzer Palma de Mallorca Spain 07198
173 Centralsjukhuset, Kristianstad Kristianstad Sweden 291 33
174 Universitetssjukhuset, Linköping Linköping Sweden 581 85
175 Citydiabetes, Stockholm Stockholm Sweden 112 21
176 Karolinska Universitetssjukhuset, Huddinge Stockholm Sweden 141 86

Sponsors and Collaborators

  • Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT05182840
Other Study ID Numbers:
  • 1378.5
  • 2021-001434-19
  • 1378-0005
First Posted:
Jan 10, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Empagliflozin

Study Results

No Results Posted as of Aug 24, 2022