BridgeMD
Metformin versus Tolvaptan in adults with Autosomal Dominant Polycystic Kidney Disease (ADPKD): a phase 3a, independent, multi-centre, 2 parallel arms randomized controlled trial
EU CTIS ID: 2024-517864-49-01
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
- 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.
- Urinary tract obstruction.
See the full eligibility criteria
- 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
- 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.
- 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.
- Urinary tract obstruction.
- 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.
- Evidence of active systemic or localized major infection at the time of screening.
- 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)
- Acute or chronic disease causing tissue hypoxia (e.g.: myocardial failure, severe arythmias, myocardial infarction, respiratory failure, liver failure, alcohol acute intoxication, alcoholism, dehydration).
- Previously diagnosed diabetes already in treatment with other hypoglycemic drugs.
- Ongoing breast feeding.
- Use of any other investigational drug or treatment up to 4 weeks before enrollment and during the treatment phase.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.