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

Primary Purpose

Endstage Renal Disease

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Physioneal 35
Physioneal 40
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endstage Renal Disease focused on measuring Physioneal 35, Physioneal 40, children, chronic peritoneal dialysis

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Pediatric Nephrology, Universiy Children's Hospital
  • Dept. of Pediatric Nephrology, University Hospital Erlangen
  • Dept. of Pediatric Nephrology, University of Hannover
  • Dept. of Nephrology, children´s hospital Memmingen
  • Dept. of Nephrology, University of Rostock

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Physioneal 35 vs. 40

Physioneal 40 vs. 35

Arm Description

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® 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

Outcomes

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.

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.

Full Information

First Posted
October 20, 2008
Last Updated
June 3, 2015
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00776191
Brief Title
Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism
Acronym
NephropaedPD01
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
al study sites stoped on 15/05/2012 because of insufficient recrutement.
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endstage Renal Disease
Keywords
Physioneal 35, Physioneal 40, children, chronic peritoneal dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physioneal 35 vs. 40
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Physioneal 40 vs. 35
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Physioneal 35
Other Intervention Name(s)
Nephropaed-PD-01/B
Intervention Description
Physioneal 35® for eight weeks, followed by Physioneal 40® for eight weeks
Intervention Type
Drug
Intervention Name(s)
Physioneal 40
Other Intervention Name(s)
Nephropaed-PD-01/B
Intervention Description
Physioneal 40® for eight weeks followed by Physioneal 35® for eight weeks
Primary Outcome Measure Information:
Title
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joerg Doetsch, Prof. Dr.
Organizational Affiliation
University Hospital Erlangen, Department of Pediatrics University Hospital Koeln
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Nephrology, Universiy Children's Hospital
City
Cologne
Country
Germany
Facility Name
Dept. of Pediatric Nephrology, University Hospital Erlangen
City
Erlangen
Country
Germany
Facility Name
Dept. of Pediatric Nephrology, University of Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Dept. of Nephrology, children´s hospital Memmingen
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Facility Name
Dept. of Nephrology, University of Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany

12. IPD Sharing Statement

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

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