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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allopurinol | Experimental | 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. |
|
| Control group | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allopurinol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Renal Function as Measured With eGFR | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing). | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xueqing Yu, M.D. & Ph.D. | 1st Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Affiliated Hospital, Sun Yet-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38299639 | Derived | Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3. |
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323 primary IgAN patients were screened for enrollment according to inclusion criteria.
Forty hyperuricemic patients with IgA nephropathy were enrolled in the 1st affiliated hospital of sun yat-sen university between July 2007 and June 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Renal Function as Measured With eGFR | Posted | Mean | Standard Deviation | eGFR(min/ml) | baseline and 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xueqing Yu , M.D. & Ph.D. | 1st Affiliated Hospital, Sun Yat-Sen University | 8620-87766335 | yuxq@mail.sysu.edu.cn |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| continue their usual therapy | Other | Patients will receive lifestyle modification and continue their usual therapy. |
|
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing). | We analysed all patient's data according to the ITT rule.And used the LOCF as the imputation technique. | Posted | Mean | Standard Deviation | Upro/cr (mg/g) | baseline and 6 months |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. | 0 | 21 | 0 | 21 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |