Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy

NCT ID: NCT00301600

Last Updated: 2010-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2006-01-31

Brief Summary

A single-center random parallel study to compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy

Detailed Description

IgA nephropathy is an immune-complex glomerulopathy that can result in capillary necrosis or extracapillary proliferation (crescents). Several studies have documented a higher incidence of hypertension and nephritic-range proteinuria in patients with the crescentic form of IgA nephropathy, suggesting that patients with this variant of the disease may have a worse prognosis. Some studies have shown that treatment with steroids and cyclophosphamide had efficacy on reducing proteinuria and preserving renal function by healing vasculitic lesions, therefore preventing the progression of glomerular sclerosis. Recent studies have also shown that mycophenolate mofetil is effective in the treatment of lupus nephritis with vasculitic lesion and small vasculitis with renal involvement. We will conduct a single-center prospective open-labeled clinical trial of 40 patients with crescentic IgA nephropathy and treat them randomly with pulse intravenous cyclophosphamide or oral mycophenolate mofetil. After 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse of mycophenolate mofetil compared with cyclophosphamide in the treatment of crescentic IgA nephropathy.

Conditions

IGA Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mycophenolate mofeti

Group Type: ACTIVE_COMPARATOR

Mycophenolate mofetil

Intervention Type: DRUG

MMF,1.0g/d

Interventions

Mycophenolate mofetil

MMF,1.0g/d

Intervention Type: DRUG

Other Intervention Names

MMF,cellcept

Eligibility Criteria

Inclusion Criteria

Patient with a diagnosis of IgAN without deposition of C4 and C1q, age 10-70y, sex free

1. Gross hematuria or an active urine sediment

2. Segmental necrotizing lesion of the capillary wall

3. Cellular or fibrocellular crescents ≥ 10%

4. Fibrinoid degeneration of small vessels

5. Fibrin positive Three or more items, with provision of criteria informed consent

Exclusion Criteria

1. More than four-week treatment with cytotoxic drug, such as CTX, CsA and MMF, prior to enrollment

2. Immune deficiency

3. Serum creatinine ≥ 5.0mg/dl

4. Previous malignancy

5. Pregnancy

6. Hepatitis

7. Diabetic mellitus or obesity

8. Severe infection or CVS complications

9. Henoch-Schonlein purpura nephritis, systemic vasculitis, SLE

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Nanjing University School of Medicine

Principal Investigators

Lei-Shi Li, M.D.

Role: STUDY_CHAIR

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Locations

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, China

Countries

China

References

Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2.

Reference Type: DERIVED

PMID: 38864363 (View on PubMed)

Other Identifiers

NJCT-0606

Identifier Type: -

Identifier Source: org_study_id