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

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ClinicalTrials.gov Identifier: NCT00776191
Recruitment Status : Terminated (al study sites stoped on 15/05/2012 because of insufficient recrutement.)
First Posted : October 21, 2008
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
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.

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)

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Study Type : Interventional  (Clinical Trial)
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 : September 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012


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 Name: 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 Name: Nephropaed-PD-01/B




Primary Outcome Measures :
  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. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  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. [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776191


Locations
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Germany
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, 30625
Dept. of Nephrology, children´s hospital Memmingen
Memmingen, Germany, 87700
Dept. of Nephrology, University of Rostock
Rostock, Germany, 18057
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Joerg Doetsch, Prof. Dr. University Hospital Erlangen, Department of Pediatrics University Hospital Koeln
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00776191    
Other Study ID Numbers: 2005-005434-12
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by University of Erlangen-Nürnberg Medical School:
Physioneal 35
Physioneal 40
children
chronic peritoneal dialysis
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency