Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Prote… (NCT00776191) | Clinical Trial Compass
TerminatedPhase 4
Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism
Stopped: al study sites stoped on 15/05/2012 because of insufficient recrutement.
Germany5 participantsStarted 2008-09
Plain-language summary
The purpose of this study is to demonstrate an increase in protein metabolism during treatment with Physioneal 35® (containing lactate 10 mmol/l, calcium 1.75 mmol/l) compared to treatment with Physioneal 40® (containing lactate 15 mmol/l, calcium 1.25 mmol/l) in children and adolescents with end stage renal failure receiving peritoneal dialysis.
Who can participate
Age range
3 Months – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are males or non-pregnant females between the ages of 3 months and 18 years.
* Patients who are on regular automated peritoneal dialysis due to end stage renal failure for at least 3 months.
* Patients and/or their parents must be capable of understanding the purpose and risks of the study.
* Patients and/or their parents (or guardians) who are willing to give written informed consent and willing to participate in and comply with the study protocol.
Exclusion Criteria:
* Use of pure lactate, amino acid or oligosaccharide solutions for peritoneal dialysis
* Peritonitis episode less than 6 weeks before enrolment
* Hypercalcemia (serum) \> 2.75 mmol/l in three independent measurements during 10 days
* Severe secondary hyperthyroidism (iPTH \> 500 ng/l)
* Renal anemia with hemoglobin (blood) \< 10 mg/dl
* Impaired hepatic function (AST/SGOT or ALT/SGPT \> 2 times the upper limit of the reference range)
* Patients who are participating in another study that requires Ethics Committee approval. Non-interventional studies are permitted.
* Pregnant female patients, females of childbearing potential who are unwilling or unable to use adequate contraception methods.
* Severe respiratory insufficiency
* Malnourishment (body weight \< -2.5 SDS for height and gender) or severe deterioration of fat metabolism
* Patients with a history of malignancy of any organ system, treated or untreated
* Any surgical or medical condition which might significantly al…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To demonstrate an increase in protein metabolism during treatment with Physioneal 35® compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis.
Timeframe: 16 weeks
Trial details
NCT IDNCT00776191
SponsorUniversity of Erlangen-Nürnberg Medical School