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.: PACTR202607678798356 Date of Registration: 30/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study of Allopurinol and Febuxostat Effects in Hyperuricemia and Chronic Kidney Disease Patients Using Serum Asymmetric Dimethyl Arginine as an Endothelial Dysfunction Marker.
Official scientific title Comparative Study of Allopurinol and Febuxostat Effects in Hyperuricemia and Chronic Kidney Disease Patients Using Serum Asymmetric Dimethyl Arginine as an Endothelial Dysfunction Marker.
Brief summary describing the background and objectives of the trial As a major risk factor for cardiovascular disease, CKD has emerged as a significant public health issue. Early detection and treatment of risk factors may stop or halt the course of a disease. Hyperuricemia hastens renal endothelial failure and renal arteriolopathy by causing microvascular damage and renal deterioration. According to epidemiologic research, elevated blood uric acid levels are a separate risk factor for cardiovascular disease and CKD. Therefore, correcting hyperuricemia will help prevent endothelial damage, protect the kidneys, and reduce the progression of CKD. This study aims at investigating whether a xanthine oxidase inhibitor (febuxostat or allopurinol) is superior in outcomes among CKD patients at Zagazig University Hospital.
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: Drugs
Anticipated trial start date 20/05/2024
Actual trial start date 20/05/2024
Anticipated date of last follow up 20/05/2025
Actual Last follow-up date 15/05/2025
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants) 150
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Allopurinol 100 mg after dialysis (three times weekly) 3 months Allopurinol is a traditional xanthine oxidase inhibitor that is used and approved for hyperuricemia. 50
Experimental Group Febuxostat 40 mg daily 3 months Febuxostat is a newer, highly potent xanthise oxidase inhibitor. 50
Control Group Usual care 3 months Patients received usual care with no active comparator to allopurinol or febuxostat. 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Adults (>=18 years old).  Patients with CKD.  Asymptomatic hyperuricemia. (SUA > 6 mg/dl)  Stable doses for all medications, including antihypertensive medications, for at least three months preceding enrollment in this study.  Stable renal function within at least 3 months before the enrollment in this study.  Pediatrics (<18 years old)  Active infections.  Acute kidney injury.  Advanced malignancy.  Serious disease.  Patients on medications such as azathioprine, mercaptopurine, cyclosporine, pyrazinamide, or ethambutol.  History of hypersensitivity to allopurinol or febuxostat. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 19/05/2024 Zagazig University Faculty of Medicine IRB
Ethics Committee Address
Street address City Postal code Country
Zagazig Zagazig, El Sharkeya 44519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Serum uric acid (mg/dL) Baseline and 3 months
Primary Outcome Estimated GFR (mL/min/1.73 m2) Baseline and 3 months
Primary Outcome Serum asymmetric dimethylarginine (µmol /L) Baseline and 3 months
Secondary Outcome Urine albumin creatinine ratio (mg/gCr) Baseline and 3 months
Secondary Outcome Serum high sensitivity C-reactive protein (mg/L) Baseline and 3 months
Secondary Outcome LDL-cholesterol (mg/dL) Baseline and 3 months
Secondary Outcome Ankle brachial index Baseline and 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Zagazig University Hospital Zagazig Sharkia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Eldougdoug Zagazig Sharkia 44519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Eldougdoug Zagazig University Zagazig Egypt Individual
Secondary Sponsor Zagazig University Faculty of Pharmacy Zagazig Zagazig Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Eldougdoug mohwagdy@pharmacy.zu.edu.eg +201020908566 Zagazig
City Postal code Country Position/Affiliation
Zagazig Egypt Zagazig University Faculty of Pharmacy
Role Name Email Phone Street address
Public Enquiries Mohamed Eldougdoug mohwagdy@pharmacy.zu.edu.eg +201020908566 Zagazig
City Postal code Country Position/Affiliation
Zagazig El Sharkia Egypt Zagazig University Faculty of Pharmacy
Role Name Email Phone Street address
Scientific Enquiries Mohamed Eldougdoug mohwagdy@pharmacy.zu.edu.eg +201020908566 Zagazig
City Postal code Country Position/Affiliation
Zagazig Egypt Zagazig University Faculty of Pharmacy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The statistical analysis plan, protocol, and further data can be provided upon reasonable request from the corresponding author. Study Protocol Not applicable Not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 24/07/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 24/07/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 16/07/2026 To provide a proper data sharing statement Not applicable The statistical analysis plan, protocol, and further data can be provided upon reasonable request from the corresponding author.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 24/07/2026 We added a summary result overview as advised No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 24/07/2026 We added a summary result overview as advised 43667_30803_1045.pdf