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

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ClinicalTrials.gov Identifier: NCT00793585
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : July 1, 2011
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: IgA Nephropathy
Interventions: Drug: allopurinol
Other: continue their usual therapy

  Participant Flow

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 changed to 100mg twice daily when serum uric acid deceased to the normal range. 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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 changed to 100mg twice daily when serum uric acid deceased to the normal range. 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 
Overall Participants Analyzed 
[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

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

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


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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



Responsible Party: Xue Qing Yu, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00793585     History of Changes
Other Study ID Numbers: SYSU-PRGIgAN-002
First Submitted: November 17, 2008
First Posted: November 19, 2008
Results First Submitted: October 28, 2009
Results First Posted: July 1, 2011
Last Update Posted: May 25, 2016