Study to evaluate the effIcacy and safety of a solution for peritoneal dialysis with a low glucose content

Phase 1

• Conditions: End-Stage Renal Disease (ESRD); MedDRA version: 21.0Level: PTClassification code 10077512Term: End stage renal diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2019-004183-21-IT
• Lead Sponsor: IPERBOREAL PHARMA S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-28
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Patients who meet all of the following criteria will be enrolled:
1.Age = 18 years
2.Diagnosed of ESRD and treated with CAPD in the last 3 months
3.In a stable clinical condition during the 3 months before screening as demonstrated by the absence of non-elective hospitalisation and major cardiovascular events
4.Have not experienced peritonitis episodes in the last 3 months
5.In treatment with Extraneal (nocturnal long-dwell exchange for at least one month);
6.In treatment with 2 or 3 short-dwell prescribed exchanges with Physioneal (including Clear-Flex bag), Fixioneal, Dianeal or Dianeal Low Calcium (1.36%, 2.27% or 3.86% glucose), or Balance, Bicavera, Bicanova or Equibalance (1.5%, 2.3%, 4.25% glucose)
7.Weekly Kt/V urea measurement > 1.7
8.Followed-up/treated by the participating clinical Center/Investigator in the last three months
9.Understanding the nature of the study and providing informed consent to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

Patients who fulfill any of the following criteria will not be enrolled:
1.History of drug or alcohol abuse in the six months prior to entering the protocol
2.In treatment with androgens
3.Clinically significant abnormal liver function test (Gamma-GT > 4 times the upper normal limit)
4.Acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low tract urinary infections, renal parenchymal infection, pericarditis, etc)
5.Expected patient’s survival shorter than trial duration
6.L-Carnitine therapy in the month prior to entering the protocol
7.Have used any investigational drug in the 3 months prior to entering the protocol
8.Female patients who are pregnant or breast-feeding.
9.Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception*
10.Patients affected by Primary Hyperoxaluria as per known medical hystory
11.Patients with serum levels of uric acid > 7.2 mg/dl (male and postmenopausal women) or > 6.0 mg/dl (premenopausal women)
12.Patients with a major cardiovascular event in the last 3 months
13.Patients with advanced cardiac failure (NYHA 4).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified