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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
      • Cologne, Germany
        • Pediatric Nephrology, Universiy Children's Hospital
      • Erlangen, Germany
        • Dept. of Pediatric Nephrology, University Hospital Erlangen
      • Hannover, Germany, 30625
        • Dept. of Pediatric Nephrology, University of Hannover
      • Memmingen, Germany, 87700
        • Dept. of Nephrology, children´s hospital Memmingen
      • Rostock, Germany, 18057
        • Dept. of Nephrology, University of Rostock

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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