Metformin therapy in Polycystic Kidney Disease: A randomized, controlled trial - Nil

Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•1.Able to provide informed consent
•2.Age 18-70 years
•3.Diagnosis of ADPKD based on radiological or genetic criteria
•4.eGFR greater than equal to 38 and less than 90 mL/min/1.73m2
•5.Presence of either
•i.One or more risk factors of progression [bilateral kidney length greater than equal to 16.5cm, total kidney volume (TKV) greater than equal to 750mL, height censored TKV (htTKV) greater than equal to 600mL/m2, Mayo class 1C/D/E or PRO-PKD score greater than equal to 6], OR
•ii.Active disease progression as evidenced by one or more of following factors [decline in eGFR greater than equal to 5mL/min/1.73m2 in one year, decline in eGFR greater than equal to 3mL/min/1.73m2 per year over five years or more, or increase in htTKV/TKV of greater than equal to 5% per year on at least 2 measurements in the past year, excluding any initial eGFR effect over the initial 3 months of tolvaptan commencement (if applicable)]
•6.For people on tolvaptan therapy, it must have been in place for at least 6 months with stable dose for at least 3 months.

•1.Diabetes mellitus or other systemic disease affecting the kidneys (excluding hypertension)
•2.Uncontrolled hypertension (Systolic BP greater than 160mmHg and/or diastolic BP greater than 100mmHg after a period of rest)
•3.Clinically significant heart failure, including but not limited to New York Heart Association Class (NYHA) III or IV
•4.Non-polycystic liver disease, including but not limited to liver enzymes (ALT, AST or Total Bilirubin) greater than 2 times the upper limit of normal, except when a diagnosis of Gilbert Syndrome exists, and/or, Child-Pugh classification score greater than equal to 5
•5.Any contraindication to metformin including abnormal liver function tests or untreated Vitamin B12 deficiency.
•6.Pregnancy or breastfeeding or planning pregnancy in the next three years.
•7.Currently taking metformin
•8.Comorbidities with contraindication for metformin use or potential to contaminate trial outcomes, specifically active cancer, history of other solid organ (kidney, heart, liver, lung, bowel) transplantations, active chronic obstructive pulmonary disease (COPD), active inflammatory bowel disease (IBD), and stoma.
•9.History of dialysis
•10.Participation in another interventional clinical trial

发起方