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NCT03764605: METROPOLIS
Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease
Phase 3 trial testing Metformin in ADPKD in 150 participants. Status unknown.
30 September 2021
Quick facts
| Lead sponsor | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 30 January 2019 |
| Primary completion | 30 September 2021 |
| Estimated completion | 30 January 2022 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
Conditions studied
- ADPKD — all drugs for ADPKD →
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Who can join
Adults 18 to 50, any sex, with ADPKD. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 people in Europe (EU). This figure is equivalent to 4 in 10.000 people and thus below the prevalence threshold of 5 in 10.000 used to designate a disease as rare in EU. Renal cyst development and expansion in ADPKD involves both fluid secretion and abnormal proliferation of cyst-lining epithelial cells. The chloride channel of the cystic fibrosis transmembrane conductance regulator (CFTR) participates in secretion of cyst fluid, and the mammalian target of rapamycin (mTOR) pathway may drive proliferation of cyst epithelial cells. CFTR and mTOR are both negatively regulated by AMP-activated protein kinase (AMPK). Metformin, a drug widely used, is a pharmacological activator of AMPK. The investigators found that metformin stimulates AMPK, resulting in inhibition of both CFTR and the mTOR pathways. Metformin induces significant arrest of cystic growth in both in vitro and ex vivo models of renal cystogenesis. In addition, metformin administration produces a significant decrease in the cystic index in two mouse models of ADPKD. These results suggest a possible role for AMPK activation in slowing renal cystogenesis as well as the potential for therapeutic application of metformin in the context of ADPKD. Thus this study aims to evaluate metformin efficacy in slowing renal cystogenesis in ADPKD as compared to the actual gold standard (Tolvaptan).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03764605
- Europe PMC full search
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Other recruiting trials for ADPKD
Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03764605 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Last refreshed: 7 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03764605.
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