Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01195194
• Date of registration: 19/04/2010
• Primary sponsor: Josep M Grinyo
• Public title: Selection of Immunosuppression in Kidney Transplant Recipients Depending on Pre-transplant Donor-specific T-cell Reactivity. SIRES
• Scientific title: Pilot Study of Selection of Either Calcineurin Inhibitor(CNI)-Based or CNI-free Immunosuppressive Regimen Depending on the Result of Pre-transplantation Donor-specific T-cell Reactivity Measured by Enzyme-linked Immunosorbent Spot(ELISPOT) in Standard-risk Kidney Recipients.
• Date of first enrolment: March 2008
• Target sample size: 61
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01195194
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Spain

Contacts

• Name: Josep M Grinyó, PhD MD
• Affiliation: Nephrology Department. Hospital de Bellvitge. Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age of donor and recipient between 18 and 65 years.

2. End-stage renal disease and scheduled to receive a primary or secondary renal
allograft from a cadaveric, a living-unrelated, or a living-related donor. Patients
scheduled for a second transplant must have maintained their primary graft for at
least 6 months after transplantation, with the exception of graft failure due to
technical reasons.

3. PRA = 20%, with negative standard cross-match.

4. Women of childbearing potential must have a negative serum pregnancy test before
randomization.

5. Women of childbearing potential must agree to use a medically acceptable method of
contraception throughout the treatment period and for 3 months following
discontinuation of assigned treatment.

6. Signed and dated informed consent prior to transplantation.

Exclusion Criteria:

1. Multiple organ transplants

2. Recipients of adult or pediatric en bloc kidney transplants or dual transplantation
or non-heart beating donors.

3. Evidence of active systemic or localized major infection.

4. Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during
the screening/baseline evaluation.

5. Use of any investigational drug or treatment up to 4 weeks prior to transplantation.

6. Treatment with voriconazole, ketoconazole, itraconazole, fluconazole, clotrimazole,
astemizole, pimozide, terfenadine, erythromycin, clarithromycin, telithromycin,
troleandomycin, rifampin, rifabutin, or St. John's Wort that is not discontinued
prior to randomization.

7. Treatment with aminoglycosides, amphotericin B, cisplatin, cisapride, metoclopramide,
cimetidine, bromocriptine, danazol, or other drugs associated with renal dysfunction
that are not discontinued prior to randomization.

8. Subjects with a screening/baseline total white blood cell count < 2,000/mm3 or ANC <
500, platelet count < 100,000/mm3.

9. Fasting triglycerides > 400 mg/dL (> 4.6 mmol/L) or fasting total cholesterol > 300
mg/dL (> 7.8 mmol/L) despite optimal lipid-lowering therapy.

10. History of malignancy within 2 years of enrollment (except for adequately treated
basal cell or squamous cell carcinoma of the skin).

11. Auto-immune diseases inactive immunosuppressive treatment ( 3 months prior to
inclusion).

12. Patient with psychiatric disorders that could be non-compliance for the treatment.

13. Non Caucasian patients.

14. Active peptic ulcers that could produce intestinal absorption disorders.

15. Subjects who are known to be HIV or HBVpositive. Patients with HCV positive should
be excluded if PCR positive or transaminates values are =2UNV.

16. Diabetic patients.

17. Body mass index higher than 30 Kg/m2.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Disorder Related to Renal Transplantation

Intervention(s)

Drug: PRE-TRANSPLANT

Primary Outcome(s)

Percentage of biopsy-confirmed acute rejection episodes [Time Frame: 6 months]

Secondary Outcome(s)

Histology at month 6 protocol kidney allograft biopsy [Time Frame: 6 months]

Percentage of acute rejection episodes requiring treatment with antilymphocyte antibodies [Time Frame: 12 months]

Percentage of acute rejection episodes requiring treatment with antilymphocyte antibodies. [Time Frame: 6 months]

Percentage of biopsy-confirmed acute rejection episodes [Time Frame: 12 months]

Percentage of patients in group A requiring CNI introduction. [Time Frame: 24 months]

Percentage of patients presenting adverse events requiring study withdrawal [Time Frame: 24 months]

Percentage of patients with negative ELISPOT [Time Frame: 12 months]

Percentage of patients with negative ELISPOT [Time Frame: 6 months]

Percentage of steroid-sensitive acute rejection episodes [Time Frame: 6 months]

Percentage of steroid-sensitive acute rejections rejection episodes [Time Frame: 12 months]

Proteinuria measured in g/day [Time Frame: 12 months]

Proteinuria measured in g/day [Time Frame: 6 months]

Renal function estimated by Modification of Diet in Renal Disease (MDRD) formula. [Time Frame: 12 months]

Secondary ID(s)

2007-002378-68

SIRES

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Carlos III Health Institute