Endstage Renal DiseasePhase 4NephropaedPD01NCT00776191
Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism
A Phase 4 study testing Physioneal 35 and Physioneal 40 in people with Endstage Renal Disease, run by University of Erlangen-Nürnberg Medical School at 5 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Endstage Renal Disease
- What is being tested?
- Physioneal 35 and Physioneal 40
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesGermany
- Study dates
- Sep 2008to May 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Pediatric Nephrology, Universiy Children's Hospital
Cologne
Dept. of Pediatric Nephrology, University Hospital Erlangen
Erlangen
Dept. of Pediatric Nephrology, University of Hannover
Hanover, 30625
Dept. of Nephrology, children´s hospital Memmingen
Memmingen, 87700
Dept. of Nephrology, University of Rostock
Rostock, 18057
About this study
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
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.
Read the 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)
- Conditions
- Endstage Renal Disease
- Being tested
- Physioneal 35, Physioneal 40
- Keywords
- Physioneal 35, Physioneal 40, children, chronic peritoneal dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physioneal 35Drug
Also called Nephropaed-PD-01/B
Physioneal 35® for eight weeks, followed by Physioneal 40® for eight weeks
Physioneal 40Drug
Also called Nephropaed-PD-01/B
Physioneal 40® for eight weeks followed by Physioneal 35® for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Physioneal 35 vs. 40 | Active comparator | 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. Receives: Drug: Physioneal 35 |
| Physioneal 40 vs. 35 | Active comparator | 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 Receives: Drug: Physioneal 40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: al study sites stoped on 15/05/2012 because of insufficient recrutement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endstage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joerg Doetsch, Prof. Dr., Principal investigator, University Hospital Erlangen, Department of Pediatrics University Hospital Koeln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776191
- Sponsor's protocol ID
- 2005-005434-12
- Other IDs
- 2005
- Acronym
- NephropaedPD01
- Status last verified
- Jun 2015
- First submitted
- 20 Oct 2008
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00776191
- Acronym / sponsor ID
- NephropaedPD01 / 2005-005434-12
- Conditions
- Endstage Renal Disease
- Keywords
- Physioneal 35, Physioneal 40, children, chronic peritoneal dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: al study sites stoped on 15/05/2012 because of insufficient recrutement.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physioneal 35 vs. 40 | Active comparator | Drug: Physioneal 35Physioneal 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 vs. 35 | Active comparator | Drug: Physioneal 40Physioneal 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 |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physioneal 35Also: Nephropaed-PD-01/BPhysioneal 35® for eight weeks, followed by Physioneal 40® for eight weeks | Drug | Physioneal 35 vs. 40 |
| Physioneal 40Also: Nephropaed-PD-01/BPhysioneal 40® for eight weeks followed by Physioneal 35® for eight weeks | Drug | Physioneal 40 vs. 35 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: al study sites stoped on 15/05/2012 because of insufficient recrutement.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg Doetsch, Prof. Dr. principal investigator
University Hospital Erlangen, Department of Pediatrics University Hospital Koeln
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physioneal 35 and Physioneal 40 in people with Endstage Renal Disease, run by University of Erlangen-Nürnberg Medical School at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: al study sites stoped on 15/05/2012 because of insufficient recrutement.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.