SIROLIMUS VERSUS MYCOPHENOLATE MOFETIL IN SIMULTANEOUS PANCREAS AND KIDNEY TRANSPLANTATION TO EVALUATE THE RISK OF HERNIA
Key facts
- Where
- Prague, CsehországSee the site
- Phase
- 4. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Csehország
- Institute for Clinical and Experimental MedicinePrague, CsehországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute For Clinical And Experimental Medicine
- Trial code
- EU 2024-517391-38-00
- Record updated
- 2024. október 8.
- Original description
To compare the incidence of incisional hernia following combined pancreas and kidney transplantation in type 1 diabetic subjects with end-stage kidney disease treated with to different immunosuppressive rengimensRead full original descriptionShow less
To compare the incidence of incisional hernia following combined pancreas and kidney transplantation in type 1 diabetic subjects with end-stage kidney disease treated with to different immunosuppressive rengimens
Inclusion: 1 Male or female patients, of 18 to 65 years of age, with a pre- or an end-stage renal failure, Type 1-diabetic nephropathy; Patient is scheduled to be put on waiting-list for a primary simultaneous pancreas/kidney (SPK) cadaver transplant.
Exclusion: Patient receives a kidney transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone; Patient has a history of an extensive abdominal operation or a hernia in the abdominal wall; Patient is allergic or intolerant to any drug comprising both immunosuppressive protocols; Patient has malignancy or history of malignancy, with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence; Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication; Patient has a positive T-cell cross-match on the most recent serum specimen; Patient is known for active liver disease or has significant liver disease; defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal; Donor is older than 65 years of age; Patient is pregnant or breastfeeding; Patient has a high immunological risk, defined as a PRA grade > 50%.