Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma
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|ClinicalTrials.gov Identifier: NCT00120263|
Recruitment Status : Completed
First Posted : July 15, 2005
Last Update Posted : May 9, 2006
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.
|Condition or disease||Intervention/treatment|
|Multiple Myeloma Acute Renal Failure||Procedure: Plasma Exchange|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma|
|Study Start Date :||September 1998|
|Estimated Study Completion Date :||April 2004|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120263
|Dr W F Clark|
|London, Ontario, Canada, N6A 4G5|
|Principal Investigator:||William F Clark, MD||University of Western Ontario, Canada|