NephropaedPD01: Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Terminated

CT.gov ID

NCT00776191

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patient Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endstage Renal Disease	Drug: Physioneal 35 Drug: Physioneal 40	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized, Multicenter Cross-over Study in Investigating the Effect of Bicarbonate-based Solutions (Physioneal 35 vs. 40) on Protein Metabolism in Children and Adolescents on Chronic Peritoneal Dialysis

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Physioneal 35 Physioneal 35® for eight weeks, followed by Physioneal 40® for eight weeks Other Names: Nephropaed-PD-01/B
Active Comparator: 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	Drug: Physioneal 40 Physioneal 40® for eight weeks followed by Physioneal 35® for eight weeks Other Names: Nephropaed-PD-01/B

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Physioneal 35

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

Other Names:

Nephropaed-PD-01/B

Active Comparator: 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

Drug: Physioneal 40

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

Other Names:

Nephropaed-PD-01/B

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Pediatric Nephrology, Universiy Children's Hospital	Cologne	Germany
2	Dept. of Pediatric Nephrology, University Hospital Erlangen	Erlangen	Germany
3	Dept. of Pediatric Nephrology, University of Hannover	Hannover	Germany	30625
4	Dept. of Nephrology, children´s hospital Memmingen	Memmingen	Germany	87700
5	Dept. of Nephrology, University of Rostock	Rostock	Germany	18057