Metformin for Autosomal dominant polycystic kidney disease (ADPKD)

Inclusion criteria

• {"criterion_text":"- Men and women aged between 18 and 55 years"}
• {"criterion_text":"- mean of eGFR (CKD-EPI) in SV1 and SV2 ≥ 45 ml/min/1,73 m2"}
• {"criterion_text":"- Genetic Diagnosis of Type I ADPKD truncating mutation"}
• {"criterion_text":"- Signed and dated informed consent"}

Exclusion criteria

• {"criterion_text":"- Women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. If employing birth control, 2 of the following precautions must be used: vasectomy of partner, tubal ligation, vaginal diaphragm, intrauterine device, condom, or sponge with spermicide. Non childbearing potential in women is defined as female subjects who are surgically sterile (ie, have undergone bilateral oophorectomy or hysterectomy) or female subjects who have been postmenopausal for at least 12 consecutive months."}
• {"criterion_text":"- Known hypersensitivity to metformin and its derivatives."}
• {"criterion_text":"- Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study."}
• {"criterion_text":"- Malignancies within three years before enrolment in the study."}
• {"criterion_text":"- HIV, HBV, HCV infection."}
• {"criterion_text":"- Urinary tract obstruction."}
• {"criterion_text":"- Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medical product (IMP)."}
• {"criterion_text":"- Treatment with acarbose, guar gum, cimetidin, phenprocoumon, oral anticoagulants, thrombolytic drugs, diuretics, ranolazin, cephalexin."}
• {"criterion_text":"- Evidence of active systemic or localized major infection at the time of screening."}
• {"criterion_text":"- Hepatic impairment or liver function abnormalities other than that expected for ADPKD with typical cystic liver disease during the screening period as defined by: AST or ALT >8x UNL; AST or ALT >5x UNL >2 WEEKS; AST or ALT >3x UNL and BT >2x UNL OR INR >1,5; AST or ALT >3x UNL and SIGNS AND SYMPTOMS OF LIVER DAMAGE (fatigue, anorexy, nausea, vomiting, right hypocondrium pain, fever, jaundice, skin rash, itching)"}
• {"criterion_text":"- Acute or chronic disease causing tissue hypoxia (e.g.: myocardial failure, severe arythmias, myocardial infarction, respiratory failure, liver failure, alcohol acute intoxication, alcoholism, dehydration)."}
• {"criterion_text":"- Previously diagnosed diabetes already in treatment with other hypoglycemic drugs."}
• {"criterion_text":"- Ongoing breast feeding."}
• {"criterion_text":"- Use of any other investigational drug or treatment up to 4 weeks before enrollment and during the treatment phase."}

Primary endpoints

• {"endpoint_text":"- Primary outcome of the study is to evaluate the treatments difference (between Metformin and Tolvaptan) in annualized slope of eGFR (CKD-epi) for individual subjects will be calculated using an appropriate baseline and post-randomization assessment","definition_or_measurement_approach":"Annualized slope of eGFR (CKD-EPI) calculated using an appropriate baseline and post-randomization assessments for each individual subject."}

Secondary endpoints

• {"endpoint_text":"- The key secondary endpoint is the percent change from baseline in htTKV as measured by CT-scan at 12 and 24 months.","definition_or_measurement_approach":"Percent change from baseline in height-adjusted total kidney volume (htTKV) measured by renal CT scan at 12 and 24 months."}

Italy

Earliest CTIS Part Ii Submission Date

14-11-2024

Latest Decision Or Authorization Date

10-03-2026

Processing Time Days

481

Number Of Sites

15

Number Of Participants

150

Primary sponsor

Full Name

University Of Bari Aldo Moro

Organisation Type

Educational Institution

Country Of Registered Address

Italy

Contract research organisations

Name

Clinical Research Technology S.r.l.

Responsibilities

sponsorDuties codes: 1,12,6,7,8

Third parties

• {"country":"Italy","full_name":"Clinical Research Technology S.r.l.","duties_or_roles":"sponsorDuties codes: 1,12,6,7,8","organisation_type":"Pharmaceutical company"}