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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120263 on ClinicalTrials.gov