- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00776191
Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism (NephropaedPD01)
June 3, 2015 updated by: University of Erlangen-Nürnberg Medical School
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
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cologne, Germany
- Pediatric Nephrology, Universiy Children's Hospital
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Erlangen, Germany
- Dept. of Pediatric Nephrology, University Hospital Erlangen
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Hannover, Germany, 30625
- Dept. of Pediatric Nephrology, University of Hannover
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Memmingen, Germany, 87700
- Dept. of Nephrology, children´s hospital Memmingen
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Rostock, Germany, 18057
- Dept. of Nephrology, University of Rostock
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Physioneal 35® for eight weeks, followed by Physioneal 40® for eight weeks
Other Names:
|
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
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Physioneal 40® for eight weeks followed by Physioneal 35® for eight weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joerg Doetsch, Prof. Dr., University Hospital Erlangen, Department of Pediatrics University Hospital Koeln
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
October 20, 2008
First Submitted That Met QC Criteria
October 20, 2008
First Posted (Estimate)
October 21, 2008
Study Record Updates
Last Update Posted (Estimate)
June 4, 2015
Last Update Submitted That Met QC Criteria
June 3, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2005-005434-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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