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

NCT ID: NCT00776191

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-05-31

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 Physioneal 40® (containing lactate 15 mmol/l, calcium 1.25 mmol/l) in children and adolescents with end stage renal failure receiving peritoneal dialysis.

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 total protein, albumin, transferrin)
• Serum thyroid function (fT3, fT4, TSH)
• Serum lipid status
• Serum markers of calcium/phosphate metabolism (PTH, calcium, ionized calcium, phosphate, alkaline phosphatase)
• Prevalence of metabolic acidosis/ alkalosis (venous sample), serum lactate
• Safety parameters (such as normalized weekly Kt/v, parameters of glucose metabolism, parameters of hepatic function, parameters of calcium-phosphate-metabolism, physical examination incl. standing height, weight, assessment of complications related to peritoneal dialysis as peritonitis, exit infections and inguinal hernia)
• Body composition (lean body mass and body fat mass/fluid)

Conditions

Endstage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physioneal 35 vs. 40

Physioneal 35® Glucose solution with Bicarbonate 25 mmol/l, Lactate 10 mmol/l, and Calcium 1.75 mmol/l for eight weeks, followed by Physioneal 40® Glucose solution Bicarbonate 25 mmol/l, Lactate 15 mmol/l, and Calcium 1.25 mmol/l for eight weeks.

Group Type: ACTIVE_COMPARATOR

Physioneal 35

Intervention Type: DRUG

Physioneal 35® for eight weeks, followed by Physioneal 40® for eight weeks

Physioneal 40 vs. 35

Physioneal 40® Glucose solution Bicarbonate 25 mmol/l, Lactate 15 mmol/l, and Calcium 1.25 mmol/l for eight weeks followed by Physioneal 35® Glucose solution with Bicarbonate 25 mmol/l, Lactate 10 mmol/l, and Calcium 1.75 mmol/l for eight weeks

Group Type: ACTIVE_COMPARATOR

Physioneal 40

Intervention Type: DRUG

Physioneal 40® for eight weeks followed by Physioneal 35® for eight weeks

Interventions

Physioneal 35

Physioneal 35® for eight weeks, followed by Physioneal 40® for eight weeks

Intervention Type: DRUG

Physioneal 40

Physioneal 40® for eight weeks followed by Physioneal 35® for eight weeks

Intervention Type: DRUG

Other Intervention Names

Nephropaed-PD-01/B; Nephropaed-PD-01/B

Eligibility 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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joerg Doetsch, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Erlangen, Department of Pediatrics University Hospital Koeln

Locations

Pediatric Nephrology, Universiy Children's Hospital

Cologne, , Germany

Dept. of Pediatric Nephrology, University Hospital Erlangen

Erlangen, , Germany

Dept. of Pediatric Nephrology, University of Hannover

Hanover, , Germany

Dept. of Nephrology, children´s hospital Memmingen

Memmingen, , Germany

Dept. of Nephrology, University of Rostock

Rostock, , Germany

Countries

Germany

Other Identifiers

2005-005434-12

Identifier Type: -

Identifier Source: org_study_id