Evaluating tests for kidney and pancreas transplant recipients
Assessing Benchmarks For Allosure And Allomap Testing in Simultaneous Kidney & Pancreas Transplant Recipients.
This study is testing if non-invasive tests can help doctors better predict and confirm kidney and pancreas transplant issues in patients who have received both organs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | nivolumab |
| Locations | 1 site (Bronx, New York) |
| Trial ID | NCT04855422 on ClinicalTrials.gov |
What this trial studies
This observational pilot study aims to monitor patients who have undergone simultaneous pancreas and kidney (SPK) transplantation to assess the effectiveness of non-invasive tests, AlloSure and AlloMap, in predicting and confirming allograft injury and rejection. The study will evaluate these tests in patients with stable allograft function and those experiencing acute rejection or complications such as BKV viremia. By understanding the independent rejection of the kidney and pancreas, the study seeks to improve diagnostic accuracy and patient outcomes post-transplant.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are SPK transplant recipients between 1 month and 3 years post-transplant.
Not a fit: Patients with a previous history of solid organ transplantation or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnosis of organ rejection, potentially improving graft survival and patient quality of life.
How similar studies have performed: While the approach of using non-invasive measures for monitoring transplant rejection is gaining traction, this specific application in SPK recipients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or Female, aged 18 years or above. * SKP transplant recipients between 1 month and 3 years after transplantation Exclusion Criteria: * Previous history of solid organ transplantation * Pregnancy
Where this trial is running
Bronx, New York
- Montefiore Medical Center — Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Enver Akalin, MD — Montefiore Medical Center
- Study coordinator: Enver Akalin, MD
- Email: eakalin@montefiore.org
- Phone: 877.287.3536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.