Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Criteria

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 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.