EVEROLIMUS VERSUS MYCOPHENOLIC ACID IN SIMULTANEOUS PANCREASAND KIDNEY TRANSPLANTATION TO EVALUATE THE DIFFERENCES INRETINAL NEOVASCULARIZATION IN PATIENTS WITH DIABETICRETINOPATHY

Active, not recruiting

Conditions: simultaneous pancreas/kidney allograft transplantation
MedDRA version: 16.1Level: LLTClassification code 10048622Term: Pancreatic transplantSystem Organ Class: 100000004865
MedDRA version: 16.1Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2013-004934-14-CZ

Lead Sponsor: Institut klinické a experimentální medicíny

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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, C¬-peptidenegative
(defined as C-peptide upper limit 0.2 nmol/l ,. If C-peptide is >
0.1 nmol/l, mixed-meal test will be performed with C-peptide upper limit
> 0.2 nmol/l).
2 Female patients of childbearing age must have a negative pregnancy
test and must agree to maintain effective birth control practice
throughout the study period (2 years).
3 Patient must have signed the Patient Informed Consent Form.
4 Patient must receive a primary simultaneous pancreas/kidney (SPK)
cadaver transplant, with either intestinal or bladder and either portal or
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systemic venous drainages.
5 Patients must have preserved sight at least on one eye with visual
acuity of at least 5/60 eye
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patient is pregnant or breastfeeding.
2. Patient is allergic or intolerant to any drug comprising both
immunosuppressive protocols
3. Patient has a positive T-cell cross-match on the most recent serum
specimen.
4. 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.
5. Patient has history of prothrombotic disorders.
6. Patient has malignancy or history of malignancy, with the exception of
adequately treated localized squamous cell or basal cell carcinoma,
without recurrence.
7. Patient has been included in another clinical trial protocol for any
investigational drug within 4 weeks prior to randomization.
8. Patient has any form of substance abuse, psychiatric disorder or
condition, which, in the opinion of the investigator, may invalidate
communication.
9. Patient receives a kidney transplant from a living donor, or receives
segmental pancreatic transplant, or a previous kidney transplant alone.
10. Pancreatic duct occlusion technique.
11. Donor is older than 65 years of age.
12. The use of any other commercial or investigational
immunosuppressive drugs is prohibited if it is not clinically indicated.
13. Patient has an immunological high risk, defined as a PRA grade >
50%