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A Randomized, Controlled Trial Evaluating the Role of ImmuKnow® in the Management of Immunosuppressants Regarding Opportunistic Infections and Acute Rejection in the Renal Transplant Patient
The purpose of this study is to demonstrate whether there are any outcome benefits of a serial ImmuKnow assays in the management of de novo renal transplant recipients.
Details
| Lead sponsor | CAMC Health System |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 4 |
| Start date | 2011-12 |
| Completion | 2012-07 |
Conditions
- Kidney Transplant Immunosuppression
Interventions
- adjustment of immunosuppressant dosages
- adjustment of the dosages of immunosuppressants
Primary outcomes
- the combo-infection rates of the 2 cohorts of renal transplant recipients within the 12-month period after a de novo kidney transplantation — 12 months
The combo-infection is defined as: If a patient either has new onset culture/or serology/or PCR positive bacterial or viral infections; or moderate neutropenia (absolute netrophile count \< 1000/microL) or need GCS-F injection or has fever \>38.5 % for longer than 24 hrs then he/she is called to have combo- infection. Percentage of such patients will be compared in Immuknow vs. control group.
Countries
United States