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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03764605 |
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Date of registration:
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29/11/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease
METROPOLIS |
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Scientific title:
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Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease. A Phase 3a, Indipendent, Multicentre, Two Parallel Arms, Randomized Controlled Trial |
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Date of first enrolment:
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January 30, 2019 |
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Target sample size:
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150 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03764605 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Loreto Gesualdo |
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Address:
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Telephone:
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+390805594040 |
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Email:
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loretoge60@gmail.com |
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Affiliation:
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Name:
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Loreto Gesualdo |
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Address:
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Telephone:
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Email:
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Affiliation:
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AOUConsorziale Policlinico di Bari |
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Name:
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Loreto Gesualdo |
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Address:
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Telephone:
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+390805594040 |
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Email:
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trialnefrobari@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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ADPKD
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Intervention(s)
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Drug: Metformin
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Drug: Tolvaptan
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Primary Outcome(s)
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Glomerular Filtration Rate (estimated by CKD-Epi formula) variation
[Time Frame: 25 months]
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Secondary Outcome(s)
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Total Kidney Volume variation (measured by non contrast enhanced Kidney CT scan)
[Time Frame: 25 months]
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Secondary ID(s)
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Eudract2018-000477-77
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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