Possibia

177138

Last Update Posted: 2013-02-07

Recruiting has ended

All Genders

accepted

18 Years-60 Years

9 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation

This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview.

Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and MMF (Group 2).

This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.

Secondary objectives of the study are:

  1. Compare the side effects of the immunosuppressive medications between both groups. This will include anaphylactic reactions, GI side-effects, bone marrow suppression, renal dysfunction, hypertension, hyperglycemic effects, and effects on lipid profile.
  2. Compare the incidence of infections between both groups.

Comparison parameters are:

  1. Pancreas and kidney graft failure
  2. Patient death
  3. Clinical and biopsy documented rejection episodes
  4. Patient dropout (non-compliance with the study protocol)
  5. Kidney function as assessed by creatinine clearance or biopsy
  6. Need to change immunosuppression regimen
  7. Quality-adjusted Life Years

Eligibility

Relevant conditions:

Diabetes Mellitus

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

locations

Contact Information

Overall Contact

No valid contacts available

Data sourced from ClinicalTrials.gov