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Pilot Study to Evaluate Safety and Efficacy of PolyCore, a Ternary Combination of Xylitol, L-Carnitine and Polydextrin, to Treat End-Stage Kidney Disease Patients Starting Peritoneal Dialysis (EXCITE)
EU CTIS ID: 2024-519366-52-00
What this study is testing
The primary objective is to evaluate the safety of PolyCore through continuous monitoring of adverse events, vital signs, and laboratory parameters.
- Therapeutic exploratory (Phase II)
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
- Adults with End-Stage Kidney Disease
- GFR ≥ 5
- Patients in treatment with peritoneal dialysis for less than 6 months (at screening visit) and in stable clinical conditions
- Patients in incremental PD treatment with 1 daily Icodextrin(7.5%)-based solution and 1 daily glucose (up to 1.5%)-based solution, according the IPD regimens allowed by the study (at screening and baseline visits)
- Understand the nature and characteristics of the study and give informed consent to participate
- Weekly Kt/V urea ≥ 1.7
You likely can't join if
- Episode of peritonitis in the last 3 months
- Hypersensitivity to any of the components of the study IMPs
- History of primary hyperoxaluria
- Patients with acute renal failure
- Presence of contraindications to the use of Polydextrin-based peritoneal dialysis solutions: allergy to starch-based polymers, maltose or isomaltose intolerance, glycogen storage disease, pre-existing severe lactic acidosis
- Patients with loss of peritoneal function or extensive adhesions compromising peritoneal function
See the full eligibility criteria
- Adults with End-Stage Kidney Disease
- GFR ≥ 5
- Patients in treatment with peritoneal dialysis for less than 6 months (at screening visit) and in stable clinical conditions
- Patients in incremental PD treatment with 1 daily Icodextrin(7.5%)-based solution and 1 daily glucose (up to 1.5%)-based solution, according the IPD regimens allowed by the study (at screening and baseline visits)
- Understand the nature and characteristics of the study and give informed consent to participate
- Weekly Kt/V urea ≥ 1.7
- Episode of peritonitis in the last 3 months
- Hypersensitivity to any of the components of the study IMPs
- History of primary hyperoxaluria
- Patients with acute renal failure
- Presence of contraindications to the use of Polydextrin-based peritoneal dialysis solutions: allergy to starch-based polymers, maltose or isomaltose intolerance, glycogen storage disease, pre-existing severe lactic acidosis
- Patients with loss of peritoneal function or extensive adhesions compromising peritoneal function
- patients with a history of abdominal surgery in the month preceding commencement of therapy, patients with abdominal fistulae, tumors, open wounds, herniae or other conditions which compromise the integrity of the abdominal wall, abdominal surface or intra-abdominal cavit
- Uncorrectable mechanical defects that prevent effective PD or increase the risk of infection.
- History of oxalate or lactate abnormalities considered clinically significant by the investigator
- History or evidence of any other medical, neurological, or psychological condition that, in the clinical judgment of the investigator, would place the subject at undue risk of a significant AE or interfere with study assessments during the course of the tri
- Enrolled in a clinical trial with an investigational product within 1 month before the start of the study
- Suspected or history of drug and/or alcohol abuse
- Severe pulmonary, cardiac, or hepatic disease/insufficiency
- Clinically significant abnormal liver function tests (Gamma-GT and/or AST and/or ALT > 2 UNL; and/or total bilirubin > 3 UNL)
- Any type of active malignancy. Patients with excised basal cell carcinoma of the skin may be included
- Female patients who are pregnant or breastfeeding, or women of childbearing potential who are not using or are refusing to use an adequate contraceptive program
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, 18-64 years, 65+ 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.