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A Controlled Study of Uric Acid on the Progression of IgA Nephropathy

This study has been completed.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00793585
First received: November 17, 2008
Last updated: June 6, 2011
Last verified: October 2009
History of Changes
Results First Received: October 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: IgA Nephropathy
Interventions: Drug: allopurinol
Other: continue their usual therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Forty hyperuricemic patients with IgA nephropathy were enrolled in the 1st affiliated hospital of sun yat-sen university between July 2007 and June 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
323 primary IgAN patients were screened for enrollment according to inclusion criteria.

Reporting Groups
  Description
Control Group Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
Allopurinol Group Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and when serum uric acid deceased to the normal range (serum UA level 6mg/dl in females and 7mg/dl in males), allopurinol was changed to 100mg twice daily. For patients with Scr 1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.

Participant Flow:   Overall Study
    Control Group     Allopurinol Group  
STARTED     19     21  
COMPLETED     17     18  
NOT COMPLETED     2     3  
Adverse Event                 1                 1  
Protocol Violation                 1                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Control Group Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
Allopurinol Group Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and when serum uric acid deceased to the normal range (serum UA level 6mg/dl in females and 7mg/dl in males), allopurinol was changed to 100mg twice daily. For patients with Scr 1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
Total Total of all reporting groups

Baseline Measures
    Control Group     Allopurinol Group     Total  
Number of Participants  
[units: participants]
 		  19     21     40  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     19     21     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  40.1  ± 10.3     39.7  ± 10.0     39.9  ± 10.1  
Gender  
[units: participants]
 		     
Female     10     8     18  
Male     9     13     22  
Region of Enrollment  
[units: participants]
 		     
China     19     21     40  



  Outcome Measures
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1.  Primary:   Change in Renal Function as Measured With eGFR   [ Time Frame: baseline and 6 months ]
  Show Outcome Measure 1

2.  Secondary:   The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).   [ Time Frame: baseline and 6 months ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Xueqing Yu , M.D. & Ph.D.
Organization: 1st Affiliated Hospital, Sun Yat-Sen University
phone: 8620-87766335
e-mail: yuxq@mail.sysu.edu.cn


No publications provided


Responsible Party: Xueqing Yu/Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00793585     History of Changes
Other Study ID Numbers: SYSU-PRGIgAN-002
Study First Received: November 17, 2008
Results First Received: October 28, 2009
Last Updated: June 6, 2011
Health Authority: China: Food and Drug Administration