None listed
Conditions
Brief 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.
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 participan
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.
Sponsors
Dr William Mulley
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 - BKVAN
Outcome results
None listed