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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

Organizational Data

DRKS-ID:
DRKS00010917
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2016-08-11
Last update in DRKS:
2021-04-13
Registration type:
Retrospective

Acronym/abbreviation of the study

Metaprol-Study

URL of the study

No Entry

Brief summary in lay language

The main goal of this study is to evaluate the influence of post-dilution On Line Haemodiafilration (OL-HDF) versus Haemodialysis (HD) on the metabolomic and proteomic profiles after 4 respectively 12 weeks treatment period in end stage renal disease patients. The renal replacement therapy with haemodialysis has become a standard care for patients with end stage renal diseases. To increase the clearance properties of dialysis membranes, synthetic high permeability membranes have been introduced. Trials have shown a benefit in all cause mortality in patients wth post-dilution On Line-Haemodiafiltration in comparison to regular Haemodialysis. Still, no biomarkers have been definitely identified to be responsible for the clinical significance. Therefore the present study will be the first to investigate the influence of On-Line Haemodiafiltration on the metabolomics/proteomics profile in comparison to regular haemodialysis. 20 subjects will be included in this mulitcenter (3 sites) trial.

Brief summary in scientific language

This is a pilot, cross-over study to generate a hypthesis why studies showed an improved clinical outcome in end stage renal disease patients treated with post-dilution On-Line Haemodiafiltration.

Health condition or problem studied

ICD10:
N28.9 - Disorder of kidney and ureter, unspecified
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Hämodialysis for 4 weeks, following On-Line Hämodiafiltration for 12 weeks
Arm 2:
On-Line Hämodiafiltration for 4 weeks, following Haemodialysis for 12 weeks

Endpoints

Primary outcome:
Change in plasma metabolomic and proteomic profiles after 4 weeks post-dilution On Line-Haemodiafiltration versus Haemodialysis treatment
Secondary outcome:
· 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

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Crossover
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
Number of study centers:
Multicenter study
Recruitment location(s):
  • Other Dialyseinstitut Graz
  • University medical center Universitätsklinik für Innere Medizin, Abteilung für Nephrologie Graz
  • Other Dialyseinstitut Feldbach

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2014-09-01
Planned study completion date:
No Entry
Actual Study Completion Date:
2015-01-01
Target Sample Size:
20
Final Sample Size:
20

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
80 Years
Additional 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.

Addresses

Primary Sponsor

Universitätsklinik für Innere Medizin, Abteilung für Nephrologie
Univ. Prof. Dr. Alexander Rosenkranz
Auenbruggerplatz 27
8036 Graz
Austria
Telephone:
+ 43 316 385 12170
Fax:
+ 43 316 385 14426
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universitätsklinik für Innere Medizin, Abteilung für Nephrologie
Univ. Prof. Dr. Alexander Rosenkranz
Auenbruggerplatz 27
8036 Graz
Austria
Telephone:
+ 43 316 385 12170
Fax:
+ 43 316 385 14426
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Medizinische Universität Graz, Clinical Research Center
MSc. Stefanie Sach-Friedl
Stiftingtalstrasse 24
8010 Graz
Austria
Telephone:
+ 43 316 385 72835
Fax:
+43 316 385 72834
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universitätsklinik für Innere Medizin, Abteilung für Nephrologie
Univ. Prof. Dr. Alexander Rosenkranz
Auenbruggerplatz 27
8036 Graz
Austria
Telephone:
+ 43 316 385 12170
Fax:
+ 43 316 385 14426
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Österreichische Forschungsförderungsgesellschaft (FFG)
1090 Wien
Austria
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Universität Graz
Auenbruggerplatz 2
8036 Graz
Germany
Telephone:
(+43)316-38513928
Fax:
(+43)316-38514348
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2014-06-30
Ethics committee number:
26-499 ex 13/14
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-08-26

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
What study data can be made available - anonymized study data: Clinical characteristics and dialysis treatment parameters. What supporting information, if any, can be provided - study protocol. Within what time frame can the data be made available - by 2023. Procedure - Relevant question via email to the PI.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
A Prospective, Randomized, Cross-Over, Open Pilot Study to Evaluate the Influence on Metabolome and Proteome in End Stage Renal Disease Patients with Post-Dilution On-Line-HDF versus Conventional Hemodialysis (METAPROL Study)
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry