Pediatric and adolescent patients with end-stage renal failure undergoing chronic peritoneal dialysis MedDRA version: 9.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease MedDRA version: 9.1 Level: LLT Classification code 10064116 Term: Continuous ambulatory peritoneal dialysis
Conditions
Interventions
Trade Name: Physioneal 35 Glucose
Pharmaceutical Form: Solution for peritoneal dialysis
INN or Proposed INN: Glucose monohydrate
CAS Number: 14431-43-7
Concentration unit: mg/ml milligram(s)/millilit
Sponsors
Universitaetsklinikum Erlangen
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 hyperparathyreoidism (iPTH > 500 ng/l) Renal anemia with hemoglobin (blood) 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 o Major deterioration of the abdominal wall (e.g. dermal infections or burns, hernia) o 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of the treatment regime with a bicarbonate based dialysis fluid of low lactate (10 mmol/l) and high calcium (1.75 mmol/l) concentration (e.g., Physioneal 35®) compared to the traditional bicarbonate based solution with higher lactate (15 mmol/l) and lower calcium (1.25 mmol/l) concentration (e.g., Physioneal 40®) on protein metabolism in children and adolescents with end stage renal failure receiving PD.;Secondary Objective: 1. Fat oxidation (13C-enrichment in expiration breath samples for U-C13-algae turnover) 2. Growth markers (plasma levels of IgF-1, IgF-BP3, leptin) 3. Biochemical markers of anabolism (plansma levels of total protein, albumin, transferrin) 4. Serum thyroid function (fT3, fT4, TSH) 5. Serum lipid status 6. Serum markers of calcium/phosphate metabolism (PTH, calcium, ionized calcium, phosphate, alkaline phosphatase) 7. Prevalence of metabolic acidosis/ alkalosis (venous sample), serum lactate 8. 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 diaylsis as peritonitis, exit infections and inguinal hernia) 9. Body composition (lean body mass and body fat mass/fluid) ;Primary end point(s): | — |
Countries
Germany
Outcome results
None listed