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

NCT00793585 | Completed Results DMC

• 1 other identifier: SYSU-PRGIgAN-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized controlled study will evaluate the effect of uric acid on the progression of IgA nephropathy.

Conditions

IgA Nephropathy

Keywords

IgA nephropathy

Outcome Measures

Primary Outcomes (1)

• Change in Renal Function as Measured With eGFR

  baseline and 6 months

Secondary Outcomes (1)

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

  baseline and 6 months

Study Arms (2)

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.

Drug: allopurinol

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.

Other: continue their usual therapy

Interventions

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.

Allopurinol

continue their usual therapy OTHER

Patients will receive lifestyle modification and continue their usual therapy.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The 1st Affiliated Hospital, Sun Yet-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• 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.

  PMID: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Xueqing Yu , M.D. & Ph.D.
• Organization: 1st Affiliated Hospital, Sun Yat-Sen University

yuxq@mail.sysu.edu.cn

8620-87766335

Study Officials

• Xueqing Yu, M.D. & Ph.D.

  1st Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: July 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 25, 2016
• Results First Posted: July 1, 2011

Record last verified: 2016-04

Locations

CN (1)