Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma
Background:Plasma exchange has been suggested to be of theoretical benefit in the treatment of acute renal failure at the onset of multiple myeloma. Two small-randomized trials provide conflicting evidence.
Objective: To assess the effect of 5 to 7 plasma exchanges in the treatment of acute renal failure at the onset of multiple myeloma.
Design: Randomized controlled trial with 4 strata (chemotherapy and dialysis dependence) from 1998 to 2004.
Setting: Hospital plasma exchange units in 14 major Canadian medical centers.
Participants: 92 voluntary patients between the ages of 18 to 81 with acute renal failure at the onset of myeloma after volume repletion and hypercalcemia.
Intervention: 5 to 7 plasma exchanges of 50 ml/Kgm of 5% Human Serum Albumin in first 10 days plus conventional therapy versus conventional therapy alone.
Measurements: The primary outcome is a composite measure of death, dialysis dependence or Modification of Diet in Renal Disease Study glomerular filtration rate (MDRD GFR) < 30mg/min/1.73 meter squared at 6 months.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma|
- Composite Outcome: Death, Dialysis, MDRD GFR < 30 ml/min/1.73 meter squared
- Cumulative survival
- Death or on dialysis at 6 months
- GFR at 6 months
- GFR change, entry to 6 months
- Dialysis Dependence at 6 months
- Coming off dialysis by 6 months
- Dialysis initiation post plasma exchange intervention
|Study Start Date:||September 1998|
|Estimated Study Completion Date:||April 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120263
|Dr W F Clark|
|London, Ontario, Canada, N6A 4G5|
|Principal Investigator:||William F Clark, MD||University of Western Ontario, Canada|