| CTRI Number |
CTRI/2025/12/099694 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Protective effects of Febuxostat in early chronic kidney disease |
|
Scientific Title of Study
|
Protective effects of Febuxostat in early CKD: A Randomized Controlled Trial at a tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Shadab Ansari |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Medicine, Jawaharlal Nehru Medical College, Aligarh Muslim University
Room 309 Medisa residency
dhorra, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7800471997 |
| Fax |
|
| Email |
nephilimshadab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shahzad Faizul Haque |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College, Aligarh Muslim University
A 15, Medical Colony, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9412517518 |
| Fax |
|
| Email |
sfhalig@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Shadab Ansari |
| Designation |
Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College, Aligarh Muslim University
Room 309 Medisa residency
dhorra, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7800471997 |
| Fax |
|
| Email |
nephilimshadab@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawahar Lal Nehru Medical College and Hospital
|
|
|
Primary Sponsor
|
| Name |
Mohammad Shadab Ansari |
| Address |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohammad Shadab Ansari |
Jawaharlal Nehru Medical College |
OPD 13 and OPD 14, OPD block, Department of Medicine, Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh
UTTAR PRADESH |
7800471997
nephilimshadab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N181||Chronic kidney disease, stage 1, (2) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (3) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Febuxostat 20mg |
To be given orally once daily for 3 months |
| Intervention |
Febuxostat 40mg |
To be given orally once daily for 3 months |
| Comparator Agent |
Placebo |
Consisting of Excipients only, to be given orally once daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Asymptomatic Hyperuricemia, with CKD stage 3 and below, attending Geneal Medicine/ Nephrology OPD and IPD
Patients with Uric acid concentration 7 to 10 mg/dl
Patients willing to give consent. |
|
| ExclusionCriteria |
| Details |
Patients with history of Gout.
Patients with Alanine or Aspartate aminotransferase level more than 3-fold the upper limit defined at the institution.
Patients on maintenance Hemodialysis therapy or Peritoneal dialysis.
Patients with Kidney transplantation.
Patients taking drugs like Thiazides or loop diuretics.
Pregnant or lactating females
Patients having received Uricosuric drugs in preceding 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of Patients showing more than 10 percent decline in eGFR in all 3 groups |
Baseline to end of the study period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in eGFR in the 3 groups |
Baseline to end of the study period |
| Changes in Uric acid levels of the 3 groups |
Baseline to end of the study period |
| Development of CKD stage 5 |
Baseline to end of the study period |
| Any Cardiovascular events |
Baseline to end of the study period |
|
|
Target Sample Size
|
Total Sample Size="177"
Sample Size from India="177"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nephilimshadab@gmail.com].
- For how long will this data be available start date provided 01-09-2026 and end date provided 01-09-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Chronic Kidney Disease (CKD) is defined by reduced renal function (eGFR less than 90 mL/min/1.73 mĀ²) or structural abnormalities lasting at least 3 months. While hyperuricemia is a potential modifiable risk factor for CKD progression, clinical evidence supporting urate-lowering therapy remains insufficient. Febuxostat is a xanthine oxidase inhibitor primarily metabolized in the liver, making it safe for patients with low Glomerular Filtration Rates (GFR). Its effect on early kidney damage is currently not well-documented. This randomized trial aims to determine if Febuxostat is non-inferior to a placebo in preventing eGFR decline among Indian patients with early CKD and asymptomatic hyperuricemia. The study seeks to address gaps regarding the effects of dose modification and potential cardiovascular benefits. |