| Trial ID: | L1272 |
| Source ID: | NCT00063817
|
| Associated Drug: |
Conditioning Regimen
|
| Title: |
Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-stage Renal Disease|Renal Transplantation|Kidney Transplantation
|
| Interventions: |
DRUG: Conditioning Regimen
|
| Outcome Measures: |
Primary: Graft Survival Twenty-Four Months Post Transplantation, Defined by kidney transplant survival at month 24 post transplantation with successful withdrawal of cyclosporine following transplantation, in the absence of maintenance immunosuppression., 24 months (2 Years) Post Transplantation | Secondary: Participant Survival, During the three-year post-transplant follow-up period for enrolled participants., Up to thirty-six months (3 Years) Post Transplantation|Graft Survival, During the three-year post-transplant follow-up period for enrolled participants., Up to thirty-six months (3 Years) Post Transplantation|Change from Baseline in Renal Function Using Serum Creatinine, Changes in serum creatinine levels from baseline through post transplantation follow-up period., Up to thirty-six months (3 Years) Post Transplantation|Number of Episodes of Acute or Chronic Graft Versus Host Disease (GVHD), Evaluations for suspected GVHD, including biopsies as appropriate, during routine and/or for cause assessments., From Week 1 through thirty-six months (3 Years) Post Transplantation|Number of Adverse Events, As defined by protocol., Participant enrollment through <=thirty-six months (3 Years) Post Transplantation
|
| Sponsor/Collaborators: |
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Collaborators: Immune Tolerance Network (ITN)
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
5
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-06
|
| Completion Date: |
2009-07
|
| Results First Posted: |
|
| Last Update Posted: |
2017-12-27
|
| Locations: |
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00063817
|
