An interventional study of allopurinol and continue their usual therapy in IgA Nephropathy, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-05-25.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
This prospective, randomized controlled study will evaluate the effect of uric acid on the progression of IgA nephropathy.
It has been reported that hyperuricemia is a risk factor for progression of IgAN. This will be a prospective, randomized study. Eligible IgAN patients will be randomized into the treatment group and the control group. Patients in treatment group will receive allopurinol and usual therapy. Patients in control group will receive usual therapy with placebo. If with hypertension, add the CCB and the β-blocker. Fasting uric acid, serum creatinine, albumin, routine blood test, urine microscopy and dipstick, proteinuria of 24 hours and blood pressure will be measured every month. After followed-up for 6 months, the curative effect of Allopurinol on blood pressure, proteinuria and the progression of IgA nephropathy will be evaluated.
262 studies on the registry are indexed under Glomerulonephritis, IGA; 102 are open to participants now.
This study's enrollment of 40 is below the median of 68 across 212 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.
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Exclusion Criteria:
Allopurinol group:allopurinol, 100-300mg/d according to the levels of Scr(serum creatinine) and UA(uric acid), for those Scr \< 1.5mg/dl (133 umol/L) at the baseline, allopurinol was given 100 mg three times daily.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.
Drug: allopurinol
Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet and continue their usual therapy.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.
Other: continue their usual therapy
Patients will receive the lifestyle modification and treatment of allopurinol (300 mg /d) and lifestyle modification for 4 weeks; when the UA level \< 6mg/dl , the dosage changed to 200mg/d.
Patients will receive lifestyle modification and continue their usual therapy.
Change in Renal Function as Measured With eGFR
Time frame: baseline and 6 months
The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).
Time frame: baseline and 6 months
Forty hyperuricemic patients with IgA nephropathy were enrolled in the 1st affiliated hospital of sun yat-sen university between July 2007 and June 2008.
| Milestone | Control Group | Allopurinol Group |
|---|---|---|
| Started | 19 | 21 |
| Completed | 17 | 18 |
| Not completed | 2 | 3 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Protocol violation | 1 | 2 |
| eGFR(min/ml) | Control Group | Allopurinol Group |
|---|---|---|
| Change in Renal Function as Measured With eGFR | 68.9 ± 36.6 | 73.2 ± 34.8 |
| Upro/cr (mg/g) | Control Group | Allopurinol Group |
|---|---|---|
| The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing). | 1170.4 ± 951.9 | 1219.3 ± 1063.6 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | 0/19 (0%) | 0/19 (0%) |
| Allopurinol Group | — | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(Participants) | Control Group | Allopurinol Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 21 | 40 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control Group | Allopurinol Group | Total |
|---|---|---|---|
| Mean | 40.1 ± 10.3 | 39.7 ± 10.0 | 39.9 ± 10.1 |
| Sex: Female, Male(Participants) | Control Group | Allopurinol Group | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 9 | 13 | 22 |
| Region of Enrollment(participants) | Control Group | Allopurinol Group | Total |
|---|---|---|---|
| China | 19 | 21 | 40 |
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Allopurinol