Status:
UNKNOWN
Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease
Lead Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Conditions:
ADPKD
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
Autosomal dominant polycystic kidney disease (ADPKD) is the most common inherited renal disorder occurring in 1:400-1:1.000 live births and affects 4 to 6 million persons worldwide and about 205.000 p...
Detailed Description
Objective of the study is to assess if a two-year course of 1500 mg oral metformin is effective and safe in treatment of ADPKD, as compared to the actual gold-standard therapy, tolvaptan (Jinarc®) Thi...
Eligibility Criteria
Inclusion
- Men and women aged between 18 and 50 years
- eGFR (CKD-EPI) ≥ 45 ml/min/1,73 m2
- Genetic Diagnosis of Type I ADPKD truncating mutation
- Signed and dated informed consent
Exclusion
- 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, birth control implant, 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.
- 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 O ALT \>8x UNL
- AST O ALT \>5x UNL \>2 WEEKS
- AST O ALT \>3x UNL E BT \>2x UNL OR INR \>1,5
- AST O ALT \>3x UNL E 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.
- 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.
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03764605
Start Date
January 30 2019
End Date
January 30 2022
Last Update
December 7 2018
Active Locations (2)
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1
AOUC "Policlinico"
Bari, Italy, 70124
2
AOUConsorziale Policlinico Di Bari
Bari, Italy, 70124