Comparing one versus seven RATG infusions for kidney transplant patients
Basiliximab with One Day or Seven Days RATG Induction Therapy in Renal Transplantation: a Matched-cohort Observational Study
Mario Negri Institute for Pharmacological Research · NCT06374095
This study is testing if giving kidney transplant patients just one infusion of a medication instead of seven can still help prevent rejection while reducing side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mario Negri Institute for Pharmacological Research (other) |
| Drugs / interventions | basiliximab |
| Locations | 1 site (Bergamo, BG) |
| Trial ID | NCT06374095 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to evaluate the risk and benefit profile of two different induction immunosuppressive regimens in kidney transplant recipients. It compares the outcomes of patients receiving a single low-dose perioperative RATG infusion against those receiving seven consecutive infusions, alongside standard induction therapy with basiliximab and steroids. The study will follow 75 kidney transplant recipients over six months to assess the effectiveness and side effects of these regimens. The goal is to determine if fewer infusions can maintain anti-rejection efficacy while minimizing risks associated with immunosuppressive therapy.
Who should consider this trial
Good fit: Ideal candidates include recipients of a single or dual kidney transplant from ideal or marginal donors who meet the specified inclusion criteria.
Not a fit: Patients receiving living donor transplants, second transplants, or those with high antibody levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a safer and more effective immunosuppressive protocol for kidney transplant patients.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating a novel exploration in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consecutive recipients of a single or dual kidney transplant from ideal or marginal donors who, from 01/04/2023 to 31/12/2023, were induced with one single perioperative RATG infusion * Consecutive recipients (Reference-Patients) of a single or dual kidney transplant from ideal or marginal donors who before 01/04/2023 were induced with seven perioperative RATG infusions (on top of the same induction and maintenance treatment used for patients receiving one single RATG infusion) Exclusion Criteria: * Living donor recipients, second transplant recipients or patients receiving a multiorgan transplant, and patients with a peak panel reactive antibody titer \>30% or positive B cell cross-match
Where this trial is running
Bergamo, BG
- ASST HPG23 - Unità di Nefrologia — Bergamo, BG, Italy (RECRUITING)
Study contacts
- Study coordinator: Piero L Ruggenenti, MD
- Email: pruggenenti@asst-pg23.it
- Phone: +3903545351
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.
Conditions: Kidney Replacement, Kidney transplant, Basiliximab, RATG induction therapy