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Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00586716
First received: December 21, 2007
Last updated: October 8, 2009
Last verified: October 2009
History of Changes

December 21, 2007
October 8, 2009
November 2004
September 2009   (final data collection date for primary outcome measure)
elimination of donor specific antibodies [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00586716 on ClinicalTrials.gov Archive Site
negative B and T cell crossmatch [ Time Frame: 1year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients
IVIG Treatment for Live-donor Renal Transplant Patients With a Positive Crossmatch and in Patients With High PRA

The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
End Stage Renal Disease
Drug: invenous immune globulins
0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments
  • Group 1
    Patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
    Intervention: Drug: invenous immune globulins
  • Group 2
    Patients who have living donors with positive crossmatch results.
    Intervention: Drug: invenous immune globulins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
October 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 12 years of age or older
  • diagnosed with end stage renal disease
  • currently receiving either hemodialysis or peritoneal dialysis
  • active on the kidney or kidney/pancreas transplant list
  • medical clearance of the kidney donor if live related transplant
  • elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list

Exclusion Criteria:

  • received IVIG within 6 months prior to enrollment
  • HIV positive
  • Positive Hepatitis Be-antigen and/or hepatitis B viral DNA
  • Selective IgA deficiency or known antibodies to IgA
  • Allergy to human immune globulin
  • Pregnant or breast feeding
Both
12 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00586716
54298
No
Okechukwu Ojogho, MD, Loma Linda University Adventist Health Sciences Center
Loma Linda University
Not Provided
Principal Investigator: Okechukwu Ojogho, MD Loma Linda Universtiy Adventist Health Sciences Center
Loma Linda University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP