Metformin for Romanian patients with autosomal dominant polycystic kidney disease
Not Applicable
Completed
- Conditions
- Autosomal Dominant Polycystic Kidney DiseaseGenetic Diseases
- Registration Number
- ISRCTN93749377
- Lead Sponsor
- Fundeni Clinical institute
- Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31337351 (added 25/07/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
1. Age = 18 years
2. Diagnosis of ADPKD based on unified ultrasonographic Pei-Ravine criteria
3. CKD G1-G5 not on dialysis.
Exclusion Criteria
1. Diabetes mellitus
2. Active infections
3. Pregnant or breastfeeding patients,
4. Known contraindication or allergy to Metformin
5. Receiving renal replacement therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the tolerability and safety of Metformin in patients with ADPKD, which included an evaluation of the number and type of gastrointestinal and non-gastrointestinal symptoms and the evaluation of hypoglycemia, lactic acidosis, death and other adverse events, measured at baseline, 1 month, 4 months, 12 months, 18 months and 24 months using patient interviews, physical exam and laboratory tests (glycemic profile, lactate levels, complete blood count, renal ultrasound).
- Secondary Outcome Measures
Name Time Method <br> 1. Change in kidney function from baseline is evaluated based on serum creatinine, estimated with CKD-EPI formula and expressed as eGFR after 1, 4, 12, and 24 months of treatment<br> 2. The number/ percentage of patients that needed renal replacement therapy is measured using patient interviews, physical exam, laboratory tests (electrolytes, acid-base, creatinine, urea) at every visit or whenever is necessary<br> 3. Change in body mass index from baseline is evaluated based on anthropometric measurements of weight and hight after 1, 4, 12, and 24 months of treatment<br>