A Randomised Controlled trial of intravenous immunoglobulin (IVIg) compared with pulse methyl-prednisolone for the treatment of chronic active antibody mediated rejection
A Randomised Controlled trial of intravenous immunoglobulin (IVIg) compared with pulse methyl-prednisolone in Renal Transplant recipients with chronic active antibody mediated rejection to determine histological change on biopsy
Dr William Mulley
50 participants
Sep 21, 2012
Interventional
Conditions
Summary
This trial seeks to determine if one of 2 currently used treatment regimens for chronic antibody mediated rejection of the renal allograft is superior to the other in terms of preventing chronic damage. The 2 arms include conversion to tacrolimus, mycophenolate and oral prednisolone with pulse methylprednisolone. Arm one has the addition of 3x monthly doses of IVIg. A second round of therapy will be offered if at 3 months a renal biopsy shows ongoing rejection. Chronic damage will be assessed by chronic allograft damage index scores at 12 months.
Eligibility
Inclusion Criteria8
- 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 Criteria13
- 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
- BKVAN
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Interventions
Treatment with intravenous methylprednisolone, 3 doses at 250mg/dose over 3 consecutive days and intravenous immunoglobulin (1gm/kg), 3 doses once per month over 3 months. The above is then repeated after 3 months if there is ongoing active rejection on follow-up biopsy. A further 2 biopsies are preformed at 6 and 12 months. Biopsies entail a local anaesthetic to the skin over the kidney and then passing a 14 gauge needle into the transplant kidney to remove a tiny core of tissue. The participant must stay in a day procedude facility for 4 hours after the procedure to monitor for complications such as bleeding. These are diagnostic procedure and are not therapeutic.
Locations(7)
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ACTRN12612000252819