A Randomised Controlled trial of intravenous immunoglobulin (IVIg) compared with pulse methyl-prednisolone for the treatment of chronic active antibody mediated rejectio

Phase 4

• Conditions: chronic active antibody mediated rejection of the renal allograft; Renal and Urogenital - Kidney disease; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12612000252819
• Lead Sponsor: Dr William Mulley

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-29
• Study Completion: 2022-12-15
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Renal transplant recipient
>6 months post-transplant

Biopsy evidence of cAMR defined by
- Activity - Peritubular capillaritis >10% and/or glomerulitis (g1 or greater)
- Chronic Changes - Transplant glomerulopathy or IFTA or peritubular capillary basement membrane multi-lamellation or fibrous intimal thickening of arteries.

Evidence of antibody activity
- DSAb and/or
- Positive C4d staining

Exclusion Criteria

Damage to extensive
- IFTA >50%
- eGFR <25ml/min
- proteinuria >3gm/day
Too aggressive
- Banff PTC score =3
- Vascular rejection
- CMR
Concomitant biopsy findings
- Recurrent or de novo GN
- Diabetic nephropathy
- Interstitial nephritis
- BKVA

Study & Design

• Study Type: Interventional
• Study Design: Not specified