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

NCT00776191 | Terminated Phase 4

• 1 other identifier: 2005-005434-12
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

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.

Conditions

Endstage Renal Disease

Keywords

Physioneal 35; Physioneal 40; children; chronic peritoneal dialysis

Outcome Measures

Primary Outcomes (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.

  16 weeks

Secondary Outcomes (1)

• To demonstrate a improved Fat oxidation during treatment with Physioneal compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis.

  16 weeks

Study Arms (2)

Physioneal 35 vs. 40

ACTIVE COMPARATOR

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.

Drug: Physioneal 35

Physioneal 40 vs. 35

ACTIVE COMPARATOR

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

Drug: Physioneal 40

Interventions

Physioneal 35 DRUG

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

Also known as: Nephropaed-PD-01/B

Physioneal 35 vs. 40

Physioneal 40 DRUG

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

Also known as: Nephropaed-PD-01/B

Physioneal 40 vs. 35

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (5)

Pediatric Nephrology, Universiy Children's Hospital

Cologne, Germany

Location

Dept. of Pediatric Nephrology, University Hospital Erlangen

Erlangen, Germany

Location

Dept. of Pediatric Nephrology, University of Hannover

Hanover, 30625, Germany

Location

Dept. of Nephrology, children´s hospital Memmingen

Memmingen, 87700, Germany

Location

Dept. of Nephrology, University of Rostock

Rostock, 18057, Germany

Location

MeSH Terms

Interventions

Physioneal 35; Physioneal 40

Study Officials

• Joerg Doetsch, Prof. Dr.

  University Hospital Erlangen, Department of Pediatrics University Hospital Koeln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: September 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

DE (5)