Randomized, multicenter cross-over study investigating the effect of bicarbonate-based solutions (Physioneal 35 vs. 40) on protein metabolism in children and adolescents on chronic peritoneal dialysis - Nephropaed-PD-01

niversitaetsklinikum Erlangen0 个研究点开始时间: 2008年5月28日最近更新: 2012年9月25日

研究概览

暂无简介。

•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

•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) < 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
•oMajor deterioration of the abdominal wall (e.g. dermal infections or burns, hernia)
•oMajor 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

发起方

niversitaetsklinikum Erlangen