Sirolimus vs Mycophenolate With Tacrolimus in Simultaneous Pancreas and Kidney Transplantation

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is prospective randomized open single center clinical study to compare effect of sirolimus vs mycophenolate tacrolimus based protocol on pancreas and kidney graft survival in simultaneous pancreas and kidney recipients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Clinical and Experimental Medicine
• Treatments: Everolimus; Mycophenolic Acid; Pancrelipase; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• Type 1 diabetes mellitus

• End stage kidney failure

• Negative CDC crossmatch

• Female patients of childbearing age must have a negative pregnancy test

• Patient must have signed the Patient Informed Consent Form.

• Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaver transplant,

Exclusion Criteria:

• Patient is pregnant or breastfeeding.

• Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, ATG, Tacrolimus

• Patient has malignancy or history of malignancy, with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence.

• Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomization.

• Patient has any form of substance abuse or psychiatric disorder or condition, which invalidate communication.

• Severe cardiac failure or severe liver failure diagnosed at the time of transplantation