Status:
TERMINATED
Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Endstage Renal Disease
Eligibility:
All Genders
3-18 years
Phase:
PHASE4
Brief 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 Physio...
Detailed Description
* Fat oxidation (13C-enrichment in expiration breath samples for U-C13-algae turnover) * Growth markers (plasma levels of IgF-1, IgF-BP3, leptin) * Biochemical markers of anabolism (plasma levels of t...
Eligibility Criteria
Inclusion
- 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
- 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 alter the absorption, distribution, metabolism, or excretion of the investigational product and the comparator, including
- Major deterioration of the abdominal wall (e.g. dermal infections or burns, hernia)
- Major deterioration of the abdominal cavity (e.g. ascites, ileus, adhesions, bowel perforation, defects of the diaphragm, tumours)
- Patients with a history of viral infections such as HIV or hepatitis B, C.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00776191
Start Date
September 1 2008
End Date
May 1 2012
Last Update
June 4 2015
Active Locations (5)
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1
Pediatric Nephrology, Universiy Children's Hospital
Cologne, Germany
2
Dept. of Pediatric Nephrology, University Hospital Erlangen
Erlangen, Germany
3
Dept. of Pediatric Nephrology, University of Hannover
Hanover, Germany, 30625
4
Dept. of Nephrology, children´s hospital Memmingen
Memmingen, Germany, 87700