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NCT02158052 · OUTCOME

Number of Participants Without Renal Allograft Rejection at 6 Months Post-transplant

Combined Bone Marrow and Renal Transplantation for Hematologic Disorders With End Stage Renal Disease · Source last updated 2022-12-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
6 Months

What was measured

The Primary Outcome is: the incidence of renal allograft rejection at 6 months post-transplant

Analysis population: One bone marrow/kidney transplant recipient was enrolled and treated on this trial.

Groups in this outcome

Bone Marrow and Kidney RECIPIENTS

Single arm combined bone marrow and kidney transplantation Tacrolimus: Tacrolimus starting on Day -1 Equine Anti-thymocyte globulin: 20 mg/kg IV on Days -3, -1, +1, +3 Kidney transplant from a related donor: On Day 0 the renal transplant is performed according to standard surgical techniques. Bone marrow transplant from a related donor: Donor bone marrow (\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed. Total body irradiation 400 centigray (200 cGy X 2): On transplant day -1

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Bone Marrow and Kidney RECIPIENTS1

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bone Marrow and Kidney RECIPIENTS1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
The Primary Outcome is: the incidence of renal allograft rejection at 6 months post-transplant
groups
  1. description
    Single arm combined bone marrow and kidney transplantation Tacrolimus: Tacrolimus starting on Day -1 Equine Anti-thymocyte globulin: 20 mg/kg IV on Days -3, -1, +1, +3 Kidney transplant from a related donor: On Day 0 the renal transplant is performed according to standard surgical techniques. Bone marrow transplant from a related donor: Donor bone marrow (\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed. Total body irradiation 400 centigray (200 cGy X 2): On transplant day -1
    id
    OG000
    title
    Bone Marrow and Kidney RECIPIENTS
param Type
COUNT_OF_PARTICIPANTS
population Description
One bone marrow/kidney transplant recipient was enrolled and treated on this trial.
reporting Status
POSTED
time Frame
6 Months
title
Number of Participants Without Renal Allograft Rejection at 6 Months Post-transplant
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice