This trial is active, not recruiting.

Condition infection in solid organ transplant recipients
Sponsor Oxford Immunotec
Start date January 2015
End date September 2017
Trial size 600 participants
Trial identifier NCT02382211, US OI 124


The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T cells [spot forming cells/million peripheral blood mononuclear cells - PBMC)]. The T-SPOT platform technology can be applied to diagnose and monitor any major disease process driven by a T cell response, including a viral disease such as cytomegalovirus (CMV) infection (the T-SPOT.CMV assay) or an allograft rejection (the T-SPOT.PRT assay).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Assessment of anti-CMV cell-mediated immunity using the change in T-SPOT counts
time frame: Change in T-SPOT counts from baseline to 365 days post transplant.

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion criteria: 1. Active candidate or recipient of a kidney transplant. Patients enrolled post-transplant must be within 6 months of transplantation and on active CMV anti-viral prophylaxis. 2. Age ≥ 18 years. 3. CMV serology of donor and recipient confirmed prior to enrollment. For seronegative subjects (R-), CMV serostatus should be confirmed within eight weeks prior to transplant by the site local laboratory. 4. Able to provide T-SPOT pre-transplant samples up to a maximum of one month prior to transplant (in the interval between Day -30 and Day 0), or at the time of enrollment if this occurs following transplantation. 5. IRB approved written Informed Consent and privacy language per national regulation (e.g., Health Insurance Portability and Accountability Act for US sites) must be obtained from the subject or legally authorized representative prior to any study related procedures, including screening evaluations and tests. Exclusion criteria: 1. Anemia prior to transplant that indicates not a candidate for blood draw. 2. On active immunosuppression within two months prior to transplant. 3. Multi-organ transplant (dual-kidney allocation is allowed). 4. Subject has received prior exposure to a CMV vaccine. 5. Subject has undergone or is planning to undergo plasmapheresis. 6. Subject requires desensitization for ABO blood type incompatibility or a positive T or B-cell crossmatch. 7. Subject is known to be HIV positive. 8. Subject is known to have a clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study.

Additional Information

Official title A Prospective Observational Trial to Evaluate the Correlation of T-SPOT® Response to CMV Infection and T Cell-mediated Acute Graft Rejection
Description Approximately 600 subjects who meet inclusion/exclusion criteria will be enrolled in the prospective, non-randomized, observational study. Sample size is based on having an adequate overall number of subjects to assess the T-SPOT.PRT endpoint (350) and the T-SPOT.CMV endpoint (250) in the defined populations. Subjects may be enrolled from pre-transplantation to post-transplantation up to completion of antiviral prophylaxis. Study duration: 37 months; 25 months to enroll all subjects with 12 months (365 days) of patient participation. Study population: All subjects enrolled in this study will be men or women, aged 18 years or older and recipients of a first or subsequent renal transplant.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Oxford Immunotec.