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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
Enrollment 40
Recruitment Details 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 323 primary IgAN patients were screened for enrollment according to inclusion criteria.
Arm/Group Title Control Group Allopurinol Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 19 21
Completed 17 18
Not Completed 2 3
Reason Not Completed
Adverse Event             1             1
Protocol Violation             1             2
Arm/Group Title Control Group Allopurinol Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 19 21 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
21
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 21 participants 40 participants
40.1  (10.3) 39.7  (10.0) 39.9  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
Female
10
  52.6%
8
  38.1%
18
  45.0%
Male
9
  47.4%
13
  61.9%
22
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 19 participants 21 participants 40 participants
19 21 40
1.Primary Outcome
Title Change in Renal Function as Measured With eGFR
Hide Description [Not Specified]
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Allopurinol Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: eGFR(min/ml)
68.9  (36.6) 73.2  (34.8)
2.Secondary Outcome
Title The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).
Hide Description [Not Specified]
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We analysed all patient's data according to the ITT rule.And used the LOCF as the imputation technique.
Arm/Group Title Control Group Allopurinol Group
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: Upro/cr (mg/g)
1170.4  (951.9) 1219.3  (1063.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Allopurinol Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Control Group Allopurinol Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Allopurinol Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Group Allopurinol Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/21 (0.00%) 
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
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