Monitoring immune response in kidney transplant patients switching to belatacept
Surveillance Pharmacologique et Immunitaire précoce après Conversion au Belatacept Chez Les Patients Ayant Subi Une Transplantation rénale : étude Pilote
This study looks at how kidney transplant patients switching to a new medication called belatacept respond over six months by collecting blood and urine samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 1 site (Tours) |
| Trial ID | NCT05632523 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on renal transplant patients who are converting from an anticalcineurin medication to belatacept. Participants will be monitored over a six-month period, during which blood and urine samples will be collected before each of the nine infusions of belatacept and in cases of rejection. The study aims to gather clinical and biological data to better understand the immune response during this transition. Consent is not required, but patients will be informed about the study and can opt out if they choose.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are renal transplant patients converting to belatacept.
Not a fit: Patients who are pregnant, breastfeeding, or have hemoglobin levels below 9g/dL may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of renal transplant patients by improving monitoring and understanding of immune responses to belatacept.
How similar studies have performed: While this approach is observational and may not have been extensively tested in this specific context, similar studies have shown promise in monitoring immune responses in transplant patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Renal transplant patient * Patient converted from an anticalcineurin to belatacept Exclusion Criteria: * Opposition to data processing * Hemoglobin \< 9g/dL * Patient under judicial protection * Pregnant or breastfeeding woman
Where this trial is running
Tours
- University hospital — Tours, France (Recruiting)
Study contacts
- Principal investigator: Philippe GATAULT — University Hospital, Tours
- Study coordinator: Philippe GATAULT
- Email: philippe.gatault@univ-tours.fr
- Phone: 02 47 47 37 46
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.