Metformin for Romanian patients with autosomal dominant polycystic kidney disease

A preliminary, single-center, prospective, interventional, single-arm study investigating the safety, tolerability and efficacy of Metformin in Romanian adult patients with autosomal dominant polycystic kidney disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93749377

Enrollment

Registered

2019-02-25

Start date

2016-04-01

Completion date

Unknown

Last updated

2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease Genetic Diseases

Interventions

Patients received an initial dose of Metformin of 500 mg/day within the first month, that was increased to 1000 mg/day (500 mg twice daily), depending on tolerance and adverse events. Patients with CK

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
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 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 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	—

Measure

Time frame

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 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 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

—

Countries

Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026