IgA Nephropathy
Conditions
Keywords
IgA nephropathy
Brief summary
This prospective, randomized controlled study will evaluate the effect of uric acid on the progression of IgA nephropathy.
Detailed description
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.
Interventions
DRUGallopurinol
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.
OTHERcontinue their usual therapy
Patients will receive lifestyle modification and continue their usual therapy.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old. 2. Biopsy-proven IgA nephropathy. 3. Proteinuria between 0.15g/d and 3.0g/d; and serum albumin level\>3.5g/dl. 4. Serum creatinine \< 3 mg/dl. 5. Uric acid \> 6 mg//dl (360umol/dl) in female; Uric acid \>7mg/dl (420umol/dl ) in male. 6. No history of taking ACEI or ARB within 2 weeks. 7. Blood pressure \< 180/110 mmHg. 8. Subjects who agree to participate in the study and sign the informed consent.
Exclusion criteria
1. Patients who have received prednisone or immunosuppressive drugs within 2 months. 2. Patients who must take ACEI or ARB due to other diseases. 3. Patients who have the history of allergy to allopurinol. 4. Unwillingness to follow the study protocol. 5. Active gout within 4 weeks. 6. Pregnancy or unwillingness to use contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Renal Function as Measured With eGFR | baseline and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing). | baseline and 6 months |
Countries
China
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 21 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 2 |
Baseline characteristics
| Characteristic | Allopurinol Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 19 Participants | 40 Participants |
| Age, Continuous | 39.7 years STANDARD_DEVIATION 10 | 40.1 years STANDARD_DEVIATION 10.3 | 39.9 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment China | 21 participants | 19 participants | 40 participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
Primary
Change in Renal Function as Measured With eGFR
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change in Renal Function as Measured With eGFR | 68.9 eGFR(min/ml) | Standard Deviation 36.6 |
| Allopurinol Group | Change in Renal Function as Measured With eGFR | 73.2 eGFR(min/ml) | Standard Deviation 34.8 |
Secondary
The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).
Time frame: baseline and 6 months
Population: We analysed all patient's data according to the ITT rule.And used the LOCF as the imputation technique.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing). | 1170.4 Upro/cr (mg/g) | Standard Deviation 951.9 |
| Allopurinol Group | The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing). | 1219.3 Upro/cr (mg/g) | Standard Deviation 1063.6 |