A multicenter, prospective, randomised, cross-over, exploratory, open pilot study to evaluate the influence on METAbolomics and PROteomics in end stage renal disease patients with post-dilution On-LINE-HDF versus conventional haemodialysis
- Conditions
- N28.9Disorder of kidney and ureter, unspecified
- Registration Number
- DRKS00010917
- Lead Sponsor
- niversitätsklinik für Innere Medizin, Abteilung für Nephrologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
• Signed informed consent prior to any study specific screening procedures.
• Male or female between 18 and 80 years of age.
• Subjects must have an arteriovenous shunt as vascular access with a blood flow > 450ml/min facilitating a blood flow rate >350ml/min, confirmed by ultrasound.
• Subjects must have a haemoglobin level between 9 and 13g/dl
• At inclusion, all subjects must have been treated for at least 1 month, three times a week with at least 240-min bicarbonate HD using a synthetic biocompatible dialysis membrane
• Subjects must be oligoanuric at the time of randomization (<400ml/day), as reported by the subjects
• Otherwise in stable health as determined by the investigator and based on medical history and routine laboratory test during the screening period.
• History of active, clinically significant, respiratory, gastrointestinal, hepatic, neurologic psychiatric, musculoskeletal, genitourinary, derma-tological, or other disorders that, in the investigator´s opinion, could affect the conduct of the study.
• Subjects who have had any major cardiovascular event within 180 days prior to randomization, including but not limited to: myocardial in-farction, unstable angina, cerebrovascular accident, pulmonary embo-lism, or New York Heart Association Class III or IV heart failure.
• Presence of cancer
• Severe hypertension (SBP >180mmHg prior to start of the dialysis session)
• Severe malnutrition (Albumin <20g/L)
• Uncontrolled secondary hyperparathyroidism (PTH>1000pg/ml)
• Positive serologic test for hepatitis B or hepatitis C or a positive result of test for HIV antibodies within the last 12 months prior to screening.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in plasma metabolomic and proteomic profiles after 4 weeks<br>post-dilution On Line-Haemodiafiltration versus Haemodialysis treatment
- Secondary Outcome Measures
Name Time Method · Change of metabolomic and proteomic profiles in pre- and postdialysis<br>plasma samples: post-dilution On Line-Haemodiafiltration versus Haemodialysis at day 1 and Visit 5<br>· Change in plasma metabolomic and proteomic profile after 12 weeks post-dilution On Line-Haemodiafiltration versus Haemodialysis treatment<br>· Change of the listed parameters in pre-dialysis plasma samples: postdilution<br>On Line-Haemodiafiltration versus Haemodialysis at day 1 and at Visit 3, 4 and 5.<br>· Standard laboratory values (haematology, clinical chemistry)<br>· Albumin<br>· Calcium<br>· Phosphate<br>· Magnesium<br>· 25-OH Vitamin D<br>· PTH (parathyroid hormone)<br>· CRP<br>· b2-microglobulin<br>· Serum amyloid A1<br>· Indoxyl sulphate<br>· p-cresyl sulphate<br>· p-cresyl glucuronide<br>· FGF23<br>· ADMA<br>· TNF-a<br>· IL-6<br>· Leptin