Overview

This trial has been completed.

Conditions endothelial dysfunction, endstage renal disease
Treatments febuxostat, placebo
Phase phase 2/phase 3
Sponsor Ain Shams University
Start date August 2016
End date October 2016
Trial size 50 participants
Trial identifier NCT02866214, phCL 35

Summary

The Purpose of this study is to determine if the Febuxostat has an effect on endothelial dysfunction on hemodialysis patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
This Group of Patients will receive Febuxostat Drug along with their Standard Treatment.
febuxostat Donifoxate
Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session
(Placebo Comparator)
This Group of Patients will receive Placebo along with their standard Treatment.
placebo
Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session. same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .

Primary Outcomes

Measure
Asymmetric Dimethylarginine physiological marker
time frame: 2 months

Secondary Outcomes

Measure
Uric Acid , physiological parameter
time frame: 2 months
High sensitivity C-reactive protein physiological marker
time frame: 2 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Outpatients on maintenance hemodialysis. - Age from 18-70 years old. - Serum Uric Acid level 7.0 mg/dL or more. - Stable clinical condition (no hospitalization in the previous 3 months) - Informed consent in accordance with the Declaration of Helsinki. Exclusion Criteria: - Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat) - History of hypersensitivity to febuxostat. - Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol. - Participant in an another clinical trial within the past 4 weeks. - Judged to be unsuitable as a subject by the attending physician

Additional Information

Official title Evaluation of the Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
Description Aim of The Work: 1- Evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis patients, through detection of: 1. Primary endpoint: • Reduction in Asymmetrical Dimethylarginine (ADMA) 2. Secondary endpoints: - Assessing the change in serum High sensitivity C-reactive protein (hsCRP) - Assessing the change in serum Uric acid - The criteria for inclusion: 1. Outpatients on maintenance hemodialysis. 2. Age from 18-70 years old. 3. Serum UA level 7.0 mg/dL or more. 4. Stable clinical condition (no hospitalization in the previous 3 months) The exclusion criteria: 1. Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat) 2. History of hypersensitivity to febuxostat. 3. Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol. 4. Participant in an another clinical trial within the past 4 weeks. 5. Judged to be unsuitable as a subject by the attending physician. After two months , the patient will be reassessed regarding: A. ADMA serum level. B. Change in serum hsCRP. C. Change in serum Uric acid level.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Ain Shams University.