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

Primary Purpose

IgA Nephropathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
allopurinol
continue their usual therapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring IgA nephropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The 1st Affiliated Hospital, Sun Yet-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Allopurinol

Control group

Arm Description

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:(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.

Outcomes

Primary Outcome Measures

Change in Renal Function as Measured With eGFR

Secondary Outcome Measures

The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).

Full Information

First Posted
November 17, 2008
Last Updated
April 25, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT00793585
Brief Title
A Controlled Study of Uric Acid on the Progression of IgA Nephropathy
Official Title
A Prospective, Randomized Controlled Study of Uric Acid on the Progression of IgA Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
IgA nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
allopurinol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
continue their usual therapy
Intervention Description
Patients will receive lifestyle modification and continue their usual therapy.
Primary Outcome Measure Information:
Title
Change in Renal Function as Measured With eGFR
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).
Time Frame
baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old. Biopsy-proven IgA nephropathy. Proteinuria between 0.15g/d and 3.0g/d; and serum albumin level>3.5g/dl. Serum creatinine < 3 mg/dl. Uric acid > 6 mg//dl (360umol/dl) in female; Uric acid >7mg/dl (420umol/dl ) in male. No history of taking ACEI or ARB within 2 weeks. Blood pressure < 180/110 mmHg. Subjects who agree to participate in the study and sign the informed consent. Exclusion Criteria: Patients who have received prednisone or immunosuppressive drugs within 2 months. Patients who must take ACEI or ARB due to other diseases. Patients who have the history of allergy to allopurinol. Unwillingness to follow the study protocol. Active gout within 4 weeks. Pregnancy or unwillingness to use contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueqing Yu, M.D. & Ph.D.
Organizational Affiliation
1st Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 1st Affiliated Hospital, Sun Yet-sen University
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

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

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