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Clinical Trial Details

Trial ID: L1124
Source ID: NCT05705271
Associated Drug: Finerenone (Kerendia, Bay94-8862)
Title: A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Type 2 Diabetes Mellitus
Interventions: DRUG: Finerenone (Kerendia, BAY94-8862)
Outcome Measures: Primary: Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs), From the first finerenone treatment date up to 30 days after the last treatment date|Number of participants with hyperkalemia events, including hyperkalemia (serum potassium \> 5.5 mmol/L), severe hyperkalemia (serum potassium \> 6.0 mmol/L), hyperkalemia leading to study drug discontinuation, hyperkalemia leading to dialysis and hyperkalemia leading to hospitalization, Up to 19 months | Secondary: Time to the first occurrence of the composite of kidney failure, a sustained decrease of at least 40% in the estimated glomerular filtration Rate (eGFR) from baseline over a period of at least 4 weeks, or death from renal cause, Up to 19 months|Time to the first occurrence of composite of cardiovascular (CV) death, nonfatal myocardial infarction, or hospitalization for heart failure (HF), Up to 19 months|Change in urine albumin-to-creatinine ratio (UACR) from baseline to 4 months, From baseline to 4 months
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 200
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02-08
Completion Date: 2025-07-03
Results First Posted:
Last Update Posted: 2025-04-04
Locations: Bhate Hospital, Karnataka, Belagavi, 590002, India|PSRI Institute of Renal Sciences, New Delhi, Delhi, 110017, India|Vardhman Mahavir Medical College & Safdarjung Hospital (VMMC-SJH), New Delhi, Delhi, 110029, India|Muljibhai Patel Urological Hospital (MPUH) (Kidney Hospital), Nadiad, Gujarat, 387001, India|Accord Superspeciality Hospital, Faridabad, Haryana, 121002, India|Kempegowda Institute of Medical Sciences Hospital & R C, Bangalore, Karnataka, 560004, India|Christian Medical College, Vellore, Kerala, 632004, India|Dr Balabhai Nanavati Hospital, Mumbai, Maharashtra,, Maharashtra, 400056, India|Global Hospital-Super Speciality And Transplant Centre, Mumbai, Maharashtra, 400012, India|Lancelot Medical Centre, Mumbai, Maharashtra, 400092, India|All India Institute of Medical Sciences, Bhubaneswar, Odisha, 751019, India|Jawaharlal Institute Of Postgraduate Medical Education and R, Gorimedu, Pondicherry, 605006, India|Government Stanley Medical College and Hospital, Chennai, Tamil Nadu, 600001, India|M.V. Hospital & Research Centre 314/30, Chowk Lucknow, Uttar Pradesh, 226003, India|Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow, Uttar Pradesh, 226 014, India|Medica Superspecialty Hospital, Kolkata, West Bengal, 700099, India|Nizam's Institute of Medical Sciences (NIMS), Hyderabad, 500082, India
URL: https://clinicaltrials.gov/show/NCT05705271