HyperuricemiaNCT07850713
Comparison of the Effect of Allopurinol Versus Febuxostat on Serum Uric Acid in Patients With Chronic Kidney Disease Associated With Hyperuricemia
A study testing Febuxostat and allopurinol in people with Hyperuricemia and Renal Insufficiency, Chronic, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
This randomized study was designed to compare how well allopurinol and febuxostat lowered blood uric acid in adults with chronic kidney disease and high uric acid levels. It was planned to include 66 participants, aged 18 to 65 years, with stage 3 to 5 chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperuricemia, Renal Insufficiency, Chronic
- What is being tested?
- Febuxostat and allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 13 May 2026to 12 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients of either gender between the ages of 18 and 65.
- According to operational standards, chronic kidney disease was diagnosed in stages 3 to 5.
- Hyperuricemia at baseline as per operational definition.
- Clinically stable chronic kidney disease without acute deterioration within the preceding 4 weeks.
- Not receiving febuxostat or allopurinol within the preceding 4 weeks, or suitable for protocol-defined washout if applicable.
Who cannot join
- Acute kidney injury or recent rapidly progressive decline in kidney function within the last 4 weeks.
- Maintenance hemodialysis or peritoneal dialysis, or planned initiation of renal replacement therapy within the next 8 weeks.
- History of kidney transplantation.
- Known hypersensitivity or prior severe adverse reaction to allopurinol or febuxostat, including suspected allopurinol hypersensitivity syndrome.
- Severe hepatic impairment or baseline alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal.
- Active symptomatic gout flare at enrollment requiring immediate anti-inflammatory escalation that would confound urate assessment.
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- Use of other urate-lowering therapies within the last 4 weeks, such as probenecid, benzbromarone, pegloticase, rasburicase, or high-dose uricosurics.
- Current chemotherapy, active malignancy with anticipated short-term clinical instability, or conditions associated with marked urate overproduction that require specialized management.
- Uncontrolled heart failure or recent major cardiovascular event within the last 3 months, if local protocol mandates cardiovascular risk restriction for febuxostat initiation.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized study was designed to compare how well allopurinol and febuxostat lowered blood uric acid in adults with chronic kidney disease and high uric acid levels. It was planned to include 66 participants, aged 18 to 65 years, with stage 3 to 5 chronic kidney disease. Participants were to be assigned to receive either febuxostat 40 mg daily or allopurinol at a dose adjusted for their level of kidney function. Treatment was planned for eight weeks, with follow-up visits at weeks 4 and 8.
The researchers hypothesized that the two medicines would differ in their effects after eight weeks. The main measure was the proportion of participants whose uric acid level reached below 6.0 mg/dL. Changes in uric acid levels and estimated kidney function were also to be compared.
- Conditions
- Hyperuricemia, Renal Insufficiency, Chronic
- Being tested
- Febuxostat, allopurinol
- Keywords
- Chronic kidney disease stages 3 to 5, Serum uric acid, Allopurinol, Febuxostat, Estimated glomerular filtration rate
- Medical subject headings
- Hyperuricemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FebuxostatDrug
40 mg orally once daily for 8 weeks.
allopurinolDrug
Stage 3: 100 mg once daily; stage 4: 50 mg once daily; stage 5: 50 mg once daily or every other day, according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Febuxostat | Experimental | Participants assigned to this group were to receive febuxostat 40 mg orally once daily for 8 weeks. Receives: Drug: Febuxostat |
| Group B - Allopurinol | Active comparator | Participants assigned to this group were to receive allopurinol orally for 8 weeks, with the starting dose determined by chronic kidney disease stage. Receives: Drug: allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Serum Uric Acid Below 6.0 mg/dL
The percentage of participants in each treatment group whose serum uric acid level was below 6.0 mg/dL at the 8-week assessment.
Measured: 8 weeks after treatment initiation
Secondary outcomes (2)
Change in Serum Uric Acid From Baseline to 8 Weeks
The mean change in serum uric acid in each treatment group, calculated as the 8-week value minus the baseline value and expressed in mg/dL.
Measured: Baseline and 8 weeks after treatment initiation
Change in Estimated Glomerular Filtration Rate From Baseline to 8 Weeks
The mean change in estimated glomerular filtration rate in each treatment group, calculated as the 8-week value minus the baseline value and expressed in mL/min/1.73 m².
Measured: Baseline and 8 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start13 May 2026
- Primary completion12 Nov 2026 (estimated)
- Study completion12 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazia Parveen, Nishtar Medical University
- Investigators
- Naveed Riaz, Principal investigator, Nishtar Hospital Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850713
- Sponsor's protocol ID
- NMU3
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Allopurinol Versus Febuxostat on Serum Uric Acid in Patients With Chronic Kidney Disease Associated With Hyperuricemia
- ClinicalTrials.gov ID
- NCT07850713
- Acronym / sponsor ID
- NMU3
- Conditions
- Hyperuricemia, Renal Insufficiency, Chronic
- Keywords
- Chronic kidney disease stages 3 to 5, Serum uric acid, Allopurinol, Febuxostat, Estimated glomerular filtration rate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized study was designed to compare how well allopurinol and febuxostat lowered blood uric acid in adults with chronic kidney disease and high uric acid levels. It was planned to include 66 participants, aged 18 to 65 years, with stage 3 to 5 chronic kidney disease. Participants were to be assigned to receive either febuxostat 40 mg daily or allopurinol at a dose adjusted for their level of kidney function. Treatment was planned for eight weeks, with follow-up visits at weeks 4 and 8.
The researchers hypothesized that the two medicines would differ in their effects after eight weeks. The main measure was the proportion of participants whose uric acid level reached below 6.0 mg/dL. Changes in uric acid levels and estimated kidney function were also to be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Febuxostat | Experimental | Drug: FebuxostatParticipants assigned to this group were to receive febuxostat 40 mg orally once daily for 8 weeks. |
| Group B - Allopurinol | Active comparator | Drug: allopurinolParticipants assigned to this group were to receive allopurinol orally for 8 weeks, with the starting dose determined by chronic kidney disease stage. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients of either gender between the ages of 18 and 65.
- According to operational standards, chronic kidney disease was diagnosed in stages 3 to 5.
- Hyperuricemia at baseline as per operational definition.
- Clinically stable chronic kidney disease without acute deterioration within the preceding 4 weeks.
- Not receiving febuxostat or allopurinol within the preceding 4 weeks, or suitable for protocol-defined washout if applicable.
Key exclusion criteria (9 listed)
- Acute kidney injury or recent rapidly progressive decline in kidney function within the last 4 weeks.
- Maintenance hemodialysis or peritoneal dialysis, or planned initiation of renal replacement therapy within the next 8 weeks.
- History of kidney transplantation.
- Known hypersensitivity or prior severe adverse reaction to allopurinol or febuxostat, including suspected allopurinol hypersensitivity syndrome.
- Severe hepatic impairment or baseline alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Febuxostat40 mg orally once daily for 8 weeks. | Drug | Group A - Febuxostat |
| allopurinolStage 3: 100 mg once daily; stage 4: 50 mg once daily; stage 5: 50 mg once daily or every other day, according to the study protocol. | Drug | Group B - Allopurinol |
Primary outcome
Percentage of Participants Achieving Serum Uric Acid Below 6.0 mg/dL
Time frame: 8 weeks after treatment initiation
The percentage of participants in each treatment group whose serum uric acid level was below 6.0 mg/dL at the 8-week assessment.
2 secondary outcomes
Change in Serum Uric Acid From Baseline to 8 Weeks
Time frame: Baseline and 8 weeks after treatment initiation
Change in Estimated Glomerular Filtration Rate From Baseline to 8 Weeks
Time frame: Baseline and 8 weeks after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveed Riaz principal investigator
Nishtar Hospital Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Febuxostat and allopurinol in people with Hyperuricemia and Renal Insufficiency, Chronic, run by Nishtar Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Serum Uric Acid Below 6.0 mg/dL (time frame: 8 weeks after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.