Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT03764605
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged between 18 and 50 years
2. eGFR (CKD-EPI) ≥ 45 ml/min/1,73 m2
3. Genetic Diagnosis of Type I ADPKD truncating mutation
4. Signed and dated informed consent
Exclusion Criteria:
1. 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.
2. Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving investigational medical product (IMP).
3. Treatment with acarbose, guar gum, cimetidin, phenprocoumon, oral anticoagulants, thrombolytic drugs, diuretics, ranolazin, cephalexin.
4. Evidence of active systemic or localized major infection at the time of screening.
5. 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)
6. Acute or chronic disease causing tissue hypoxia (e.g.: myocardial failure, severe arythmias, myocardial infarction, respiratory failure, liver failure, alcohol acute intoxication, alcoholism, dehydration).
7. Previously diagnosed diabetes already in treatment with other hypoglycemic drugs.
8. Ongoing breast feeding.
9. Use of any other investigational drug or treatment up to 4 weeks before enrollment and during the treatment phase.
10. Known hypersensitivity to metformin and its derivatives.
11. Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study.
12. Malignancies within three years before enrolment in the study.
13. HIV, HBV, HCV infection.
14. Urinary tract obstruction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03764605
Study Brief:
Protocol Section:
NCT03764605