Cardiovascular (CV) risk prediction and CV biomarkers in renal transplant recipients treated with belatacept compared to calcineurin inhibitors (CNI)Open randomized 12 month study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 105

Inclusion Criteria

1. Signed Written Informed Consent
2. Target Population:
2.a Renal transplant recipients of living donor or deceased donor kidney transplant.
2.b Stable renal graft (eGFR > 20 ml/min)
2.c Tacrolimus or CsA (Cyclosporine A) standard treatment since transplantation
2.d 3 – 60 months post-transplantation at randomization
3. Age and Sex:
3.a Men and women, aged 18 to 80 years, both inclusive.
3.b Women of childbearing potential (WOCBP) must be using adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug to minimize the risk of pregnancy.
WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
•Amenorrhea that has lasted for ? 12 consecutive months without another cause, or
•For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where their partner is sterile (e.g. vasectomy) should be considered to be of childbearing potential.
WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of the investigational product (belatacept).
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Sex and Reproductive Status:
1.a Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug.
1.b Women who are pregnant or breastfeeding.
1.c Women with a positive pregnancy test.
2. Target Disease Exceptions: Subjects who are Epstein-Barr virus EBV) Ig negative or have unknown IgG status for EBV.
3. Medical History and Concurrent Diseases:
3.a De novo or recurrent underlying renal disease that, in the investigator’s opinion, could adversely influence the current allograft
3.b History of vascular or antibody-mediated rejection in the present transplant
3.c Ongoing serious infections, as per investigator’s opinion
3.d Signs of post-transplant lymphoproliferative disorder
3.e History of tuberculosis
3.f Signs of malignancy. Exceptions re BCC/SCC and non-malignant melanoma
3.g History of malignancy, unless subject has been considered to have fully recovered from malignancy since >1 year, without any signs of relapse.
3.h Life expectancy < 3 years at the time of randomization
4. Allergies and Adverse Drug Reactions:
4.a Hypersensitivity to belatacept
4.b Previous/ongoing use of rituximab
5. Other Exclusion Criteria:
5.a Prisoners, or subjects who are involuntarily incarcerated.
5.b Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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