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
- Conditions
- Chronic kidney disease, unspecified, (2) ICD-10 Condition: E132||Other specified diabetes mellituswith kidney complications,
- Registration Number
- CTRI/2022/03/041244
- Lead Sponsor
- Boehringer Ingelheim International GmbH
- Brief Summary
This study is open to adults with chronic kidneydisease. People with and without type 2 diabetes can take part in this study
The purpose of this study is to find outwhether a medicine called BI 690517 improves kidney function in people withchronic kidney disease when taken alone or in combination with a medicinecalled 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 anymedicine.
In the second part, participants aredivided into several groups. Depending on the group, the participants thenadditionally take different doses of BI 690517 or placebo as tablets for 3.5months. In this case, placebo tablets look like BI 690517 tablets but do notcontain any medicine.
Participants are in the study for about 6months. During this time, they visit the study site about 12 times. Wherepossible, about 4 of the 12 visits can be done at the participant’s homeinstead of the study site. The trial staff may also contact the participants byphone or video call.
Participants collect urinesamples at home. These samples are then analysed to assess kidney function. Atthe end of the trial the results are compared between the different groups. Thedoctors also regularly check participants health and take note of any unwantedeffects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 552
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- 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 2) Male or female patients of legal adult age (according to local legislation) and aged greater than or equal to 18 years at time of consent 3) estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) greater than or equal to 30 and less than 90 mL/min/1.73 m2 at Visit 1 by central laboratory analysis 4) Urine Albumin Creatinine Ratio (UACR) greater than or equal to 200 and less than 5,000 mg/g in spot urine (midstream urine sample) by central laboratory analysis at Visit 1.1 5) 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 less than or equal to 10 mg or equivalent) 6) Treatment with a clinically appropriate, stable dose of either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) (but not both together), for greater than or equal to 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial 7) In the Investigators 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 investigators judgement) within 4 weeks prior to Visit 1 and until first randomisation 8) Glycated Haemoglobin (HbA1c) less than 10.0% at Visit 1 measured by the central laboratory 9) Serum potassium less than or equal to 4.8 mmol/L at Visit 1 measured by the central laboratory 10) Seated Systolic Blood Pressure (SBP) greater than or equal to 110 and less than or equal to 160 mmHg and Diastolic Blood Pressure (DBP) greater than or equal to 65 and less than or equal to 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 investigators judgement 11) Body Mass Index (BMI) greater than or equal to 18.5 and less than 50 kg/m2 at Visit 1 12) 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): 13) Serum potassium less than or equal to 4.8 mmol/L measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period 14) eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) greater than or equal to 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
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- 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 2) 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 3) Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA)) 4) Patients at increased risk of ketoacidosis in the opinion of the investigator 5) Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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
Trial Locations
- Locations (13)
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Galaxy Lifecare Services Pvt Ltd
🇮🇳Varanasi, UTTAR PRADESH, India
Ganesh Shankar Vidyarthi Memorial Medical College
🇮🇳Nagar, UTTAR PRADESH, India
Government Medical College and Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Jaipur National University Institute for Medical Science & Research Centre
🇮🇳Jaipur, RAJASTHAN, India
K R Hospital
🇮🇳Mysore, KARNATAKA, India
Kingsway Hospitals
🇮🇳Nagpur, MAHARASHTRA, India
Max Super Specialty Hospital
🇮🇳Delhi, DELHI, India
Muljibhai Patel Urological Hospital
🇮🇳Kheda, GUJARAT, India
Scroll for more (3 remaining)All India Institute of Medical Sciences🇮🇳Delhi, DELHI, IndiaDr Raj Kawar YadavPrincipal investigator01126588500rkyadavnephrology@gmail.com