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

Phase 4

Terminated

• Conditions: Endstage Renal Disease
• Interventions: Drug: Physioneal 35; Drug: Physioneal 40

• Registration Number: NCT00776191
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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)

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Physioneal 35 vs. 40	Physioneal 35	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.
Physioneal 40 vs. 35	Physioneal 40	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Pediatric Nephrology, Universiy Children's Hospital; 🇩🇪 Cologne, Germany

Dept. of Pediatric Nephrology, University Hospital Erlangen; 🇩🇪 Erlangen, Germany

Dept. of Pediatric Nephrology, University of Hannover; 🇩🇪 Hannover, Germany

Dept. of Nephrology, children´s hospital Memmingen; 🇩🇪 Memmingen, Germany

Dept. of Nephrology, University of Rostock; 🇩🇪 Rostock, Germany