Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401461617766 Date of Registration: 02/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Removal of Adiponectin and Complement Factor D in High dose hemodiafiltration versus High flux hemodialysis.
Official scientific title Removal of Adiponectin and Complement Factor D in High dose hemodiafiltration versus High flux hemodialysis.
Brief summary describing the background and objectives of the trial Adiponectin and Complement Factor D are harmful large middle molecules that accumulate in patients with end stage renal disease. High-dose hemodiafiltration(HDF) has recently shown a clear survival benefit. Hemodiafiltration uses convection in combination with diffusive clearance to remove large middle molecules. In this study we aimed to compare the removal of adiponectin and complement factor D in patients on high- dose hemodiafiltration versus high flux hemodialysis (HD) using two different high flux dialysers. Method This is a prospective, cross over, clinical trial. Twenty hemodialysis patients > 18 years were enrolled. Dialyser and treatment efficacies were examined during a mid-week session with the following treatments HD FX 80, HD Allmed, HDF FX80, HDF Allmed. Treatment efficacy was assessed by measuring Adiponectin and Complement Factor D before and after each session.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/12/2022
Actual trial start date 01/09/2023
Anticipated date of last follow up 05/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hemodialysis session using FX80 Dialyser 1 session 4 hours The sessions were regular 4-hour sessions using bicarbonate dialysate and anticoagulation with low molecular weight heparin in the beginning of the session. Fresenius 4008S machines were used for hemodialysis 20
Experimental Group Hemodialysis session using Allmed polypure dialyser 1 session 4 hours The sessions were regular 4-hour sessions using bicarbonate dialysate and anticoagulation with low molecular weight heparin in the beginning of the session. Fresenius 4008S machines were used for hemodialysis 20
Experimental Group Hemodiafltration session using FX80 Dialyser 1 session 4 hours The sessions were regular 4-hour sessions using bicarbonate dialysate and anticoagulation with low molecular weight heparin in the beginning of the session. Fresenius 5008S CorDiax for hemodiafiltration. HDF sessions with substitution goal >23 litres, blood flow > 300 ml/min. Dialysate flow >500ml/min). 20
Control Group Hemodialysis 1 session fx60 4 hours The sessions were regular 4-hour sessions using bicarbonate dialysate and anticoagulation with low molecular weight heparin in the beginning of the session. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Twenty patients older than 18 years of age who have been on regular haemodialysis were enrolled. These patients were on high flux filter FX 60 for more than 6 months on a regular schedule of 4-hour sessions thrice weekly. All patients had arteriovenous fistula (AVF). These patients had no residual kidney function. Patients with active infection, malignancy, dialysis catheters, decompensated heart failure, liver failure and patients who were non-complaint on haemodialysis were excluded. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/09/2022 Ain shams ethical comittee
Ethics Committee Address
Street address City Postal code Country
38 Abbassia street, Next to the Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome removal of Adiponectin and Complement factor D Before and after each session
Primary Outcome Removal of Adiponectin and complement factor D Before and after each session
Secondary Outcome urea reduction ratio, potassium removal and bicarbonate increase before and after each session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university specialised hospital 59 Abassia street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No source NA Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain shams university Faculty of medicine 38 Abbassia street Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Fayez mahmoud.faiez@medasu.edu.eg 010110605731 Ain shams
City Postal code Country Position/Affiliation
Cairo 1181 Egypt Assistant lecturer of medicine and Nephrology
Role Name Email Phone Street address
Public Enquiries lamis khedr lamis.khedr@med.asu.edu.eg 01276209993 abassia street
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Nephrology
Role Name Email Phone Street address
Scientific Enquiries Lamis khedr lamis.khedr@med.asu.edu.eg 01276209993 abassia street
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of Nephrology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text,tables, figures, and appendices) Informed Consent Form,Study Protocol Beginning 3 months till 12 months after journal publication Upon reasonable request to Dr Lamis khedr at lamis.khedr@med.asu.edu.eg
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information