NL-OMON45007
Completed
Phase 4
Cardiovascular (CV) risk prediction and CV biomarkers in renal transplant recipients treated with belatacept compared to calcineurin inhibitors (CNI).;Open randomized 12 month study. - Nulojix study
niversity Hospital Uppsala0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- cardiovascular risk during prophylaxis of graft rejection in renal transplant recipients
- Sponsor
- niversity Hospital Uppsala
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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) with no need for exploratory examination)
- •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
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 IgG 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
Outcomes
Primary Outcomes
Not specified
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