Randomized, multicenter cross-over study investigating the effect of bicarbonate-based solutions (Physioneal 35 vs. 40) on protein metabolism in children and adolescents on chronic peritoneal dialysis - Nephropaed-PD-01

• Conditions: Pediatric and adolescent patients with end-stage renal failure undergoing chronic peritoneal dialysis; MedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney disease; MedDRA version: 9.1Level: LLTClassification code 10064116Term: Continuous ambulatory peritoneal dialysis

• Registration Number: EUCTR2005-005434-12-DE
• Lead Sponsor: niversitaetsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-28
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 hyperparathyreoidism (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
oMajor deterioration of the abdominal wall (e.g. dermal infections or burns, hernia)
oMajor 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

Study & Design

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