Trial of Plasma Exchange for Acute Renal Failure at the Onset of Myeloma
NCT00120263 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92
Last updated 2025-03-25
Summary
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.
Conditions
- Multiple Myeloma
- Acute Renal Failure
Interventions
- PROCEDURE
-
Plasma Exchange
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
The Kidney Foundation of Canada
collaborator OTHER -
London Health Sciences Centre
lead OTHER
Principal Investigators
-
William F Clark, MD · Western University, Canada
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 81 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1998-09-30
- Completion
- 2004-04-30
Countries
- Canada
Study Locations
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