Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

Recruiting Phase 3 Interventional Study
End Stage Renal Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
170 (estimated)
Sponsor
Iperboreal Pharma Srl · Industry
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About This Trial
Randomized, controlled, parallel groups, open-label, blinded end-point assessment, multicenter study, comparing the effects of a low glucose peritoneal dialysis solution, XyloCore, to glucose solutions (Physioneal, Fixioneal, Dianeal, Balance, Bicavera, Bicanova or Equibalance) only regimen, in patients with End-Stage Renal Disease (ESRD) receiving Continuous Ambulatory Peritoneal Dialysis (CAPD),…
Trial Locations
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Eligibility Criteria
INCLUSION CRITERIA: 1. Age ≥18 years 2. Diagnosed with ESRD and treated with CAPD in the last 3 months 3. In stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalization and major cardiovascular events 4. Have not experienced peritoni…
Contacts

Arduino Arduini, MD

+39.333.6409595

a.arduini@iperboreal.com

CONTACT