A Study of Glucothera Plus for Peritoneal Dialysis in Children (ASTRA)

Phase 1

• Conditions: End-stage Kidney Disease; MedDRA version: 21.0Level: PTClassification code: 10077512Term: End stage renal disease Class: 100000004857; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

• Registration Number: CTIS2024-512078-88-00
• Lead Sponsor: Iperboreal Pharma S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Male and female patients younger than 18 years old, Diagnosed with ESRD and in treatment with CAPD or APD for the last 6 months, L-carnitine plasma level =30 nmol/ml, Dwell volume from 800 ml/m2 to 1200 ml/m2 body surface, Have not experienced peritonitis episodes in the last 3 months, Provided written informed consent to participate in the study

Exclusion Criteria

Male and female patients = 18 years old, Impeding/major abdominal surgery, Enrolment in another clinical trial involving medical or device based interventions during a) the 30 days before the screening or b) 5-times the halflife of the used investigational product (the longest period should be considered)., Ipersensibility to Glucose, L-Carnitine and other Glucothera Plus components, Evidence of any condition that, according to the investigators’ judgment, could expose the subject to undue risk and/or prevent the subject from participating in the study procedures and/or potentially affecting the study quality data., Female patients who are pregnant or breast-feeding or women of childbearing potential* not receiving adequate contraceptive methods, Subjects with reduced efficiency of peritoneal dialysis due to anatomic anomalies or intraperitoneal adesions, Uncontrolled hyperphosphatemia, Participation in a clinical trial with an investigational drug within one month prior start of study. Prior participation in this trial, Suspicion of drug abuse, Severe pulmonary, cardiac or hepatic disease/insufficiency, Clinically significant abnormal liver function test (Gamma-GT > 4 times the upper normal limit and/or transaminases (AST and/or ALT) > 3 upper normal limits), Any kind of malignancy, Lack of appropriate caregiver support

Study & Design

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