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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00010917 |
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Date of registration:
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11/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 - Metaprol-Study |
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Date of first enrolment:
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01/09/2014 |
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Target sample size:
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20 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00010917 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: crossover; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Austria
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Contacts
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Name:
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Alexander
Rosenkranz |
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Address:
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Auenbruggerplatz 27
8036
Graz
Austria |
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Telephone:
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+ 43 316 385 12170 |
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Email:
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alexander.rosenkranz@medunigraz.at |
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Affiliation:
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Universitätsklinik für Innere Medizin, Abteilung für Nephrologie |
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Name:
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Stefanie
Sach-Friedl |
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Address:
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Stiftingtalstrasse 24
8010
Graz
Austria |
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Telephone:
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+ 43 316 385 72835 |
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Email:
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stefanie.sach-friedl@medunigraz.at |
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Affiliation:
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Medizinische Universität Graz, Clinical Research Center |
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Key inclusion & exclusion criteria
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Inclusion criteria: • 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.
Exclusion criteria: • 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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Disorder of kidney and ureter, unspecified
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N28.9
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N28.9
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Intervention(s)
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Group 1: Hämodialysis for 4 weeks, following On-Line Hämodiafiltration for 12 weeks
Group 2: On-Line Hämodiafiltration for 4 weeks, following Haemodialysis for 12 weeks
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Primary Outcome(s)
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Change in plasma metabolomic and proteomic profiles after 4 weeks
post-dilution On Line-Haemodiafiltration versus Haemodialysis treatment
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Secondary Outcome(s)
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· Change of metabolomic and proteomic profiles in pre- and postdialysis
plasma samples: post-dilution On Line-Haemodiafiltration versus Haemodialysis at day 1 and Visit 5
· Change in plasma metabolomic and proteomic profile after 12 weeks post-dilution On Line-Haemodiafiltration versus Haemodialysis treatment
· Change of the listed parameters in pre-dialysis plasma samples: postdilution
On Line-Haemodiafiltration versus Haemodialysis at day 1 and at Visit 3, 4 and 5.
· Standard laboratory values (haematology, clinical chemistry)
· Albumin
· Calcium
· Phosphate
· Magnesium
· 25-OH Vitamin D
· PTH (parathyroid hormone)
· CRP
· b2-microglobulin
· Serum amyloid A1
· Indoxyl sulphate
· p-cresyl sulphate
· p-cresyl glucuronide
· FGF23
· ADMA
· TNF-a
· IL-6
· Leptin
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Source(s) of Monetary Support
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Österreichische Forschungsförderungsgesellschaft (FFG)
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Ethics review
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Status: Approved
Approval date: 26/08/2014
Contact:
ethikkommission@medunigraz.at
Ethikkommission der Medizinischen Universität Graz
(+43)316-38513928
ethikkommission@medunigraz.at
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