Compares metformin with tolvaptan for kidney decline in polycystic kidney disease
Tests metformin against tolvaptan in adults with polycystic kidney disease.
Plain-language title generated from the registry record
Registry title: Metformin versus Tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD): a phase 3a, independent, multi-centre, 2 parallel arms randomized controlled trial
Key facts
- Where
- Bari, Bologna, Brescia, cagliari, Catania, Foggia, Messina, Milano, Napoli, Roma, San Giovanni Rotondo, and Vicenza, ItalySee the 15 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT03764605, who can take part
Where in Italy
- Azienda Ospedaliera Universitaria Federico IIItalyTaking people
- Azienda Ospedaliero-Universitaria di Modena (AOU Modena) - Policlinico di ModenaItalyTaking people
- Complesso Ospedaliero di Belcolle - Ospedale BelcolleItalyTaking people
- University Hospital Consorziale PoliclinicoBari, ItalyTaking people
- IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola MalpighiBologna, ItalyTaking people
- ASST Spedali Civili di BresciaBrescia, ItalyTaking people
- Azienda di Rilievo Nazionale ed Alta Specializzazione - ARNAS “G. Brotzu” (Ente)cagliari, ItalyTaking people
- A. O. U. Policlinico G. Rodolico-San Marco - Presidio Ospedaliero San MarcoCatania, ItalyTaking people
- Azienda Ospedaliero Universitaria Ospedali Riuniti-Policlinico di FoggiaFoggia, ItalyTaking people
- A.O.U. Gaetano MartinoMessina, ItalyTaking people
- IRCCS - Ospedale San RaffaeleMilano, ItalyTaking people
- Azienda ospedaliero universitaria -Universita degli Studi della Campania Luigi VanvitelliNapoli, ItalyTaking people
- Policlinico Universitario Agostino Gemelli IRCCS Università Cattolica Del Sacro CuoreRoma, ItalyTaking people
- Ospedale Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyTaking people
- Ospedale San Bortolo di VicenzaVicenza, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Of Bari Aldo Moro
- Trial code
- NCT03764605EU 2024-517864-49-01
- Record updated
- 10 March 2026
- Original description
Primary objective of the study is to define if a two years course of 1500 mg a day of metformin is equivalent or not inferior to tolvaptan in reducing eGFR decline in patients affected by ADPKDRead full original descriptionShow less
Metformin versus Tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD): a phase 3a, independent, multi- centre, 2 parallel arms randomized controlled trial
Primary objective of the study is to define if a two years course of 1500 mg a day of metformin is equivalent or not inferior to tolvaptan in reducing eGFR decline in patients affected by ADPKD
Inclusion: Men and women aged between 18 and 55 years; mean of eGFR (CKD-EPI) in SV1 and SV2 ≥ 45 ml/min/1,73 m2; Genetic Diagnosis of Type I ADPKD truncating mutation; Signed and dated informed consent.
Exclusion: Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medical product (IMP); Treatment with acarbose, guar gum, cimetidin, phenprocoumon, oral anticoagulants, thrombolytic drugs, diuretics, ranolazin, cephalexin; Previously diagnosed diabetes already in treatment with other hypoglycemic drugs; Use of any other investigational drug or treatment up to 4 weeks before enrollment and during the treatment phase; Known hypersensitivity to metformin and its derivatives; Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study; Malignancies within three years before enrolment in the study; HIV, HBV, HCV infection; Evidence of active systemic or localized major infection at the time of screening; Acute or chronic disease causing tissue hypoxia (e.g.: myocardial failure, severe arythmias, myocardial infarction, respiratory failure, liver failure, alcohol acute intoxication, alcoholism, dehydration); 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); 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; Urinary tract obstruction; Ongoing breast feeding.