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A Study of Glucothera Plus for Peritoneal Dialysis in Children (ASTRA)
EU CTIS ID: 2024-512078-88-00
What this study is testing
Demonstrate the safety of Glucothera Plus in the pediatric population
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.