Phase 2
N=74
Reparixin in Prevention of Delayed Graft Function After Kidney Transplantation
Ischemia-Reperfusion Injury · Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00248040 ↗Enrolled (actual)
74
Serious AEs
35.1%
Results posted
Apr 2020
Primary outcome: Primary: Creatinine Clearance (CrCl) in the Immediate Post-transplant Period — 5.11; 7.44; 6.30; 9.66 mL/min — p=0.9076
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Reparixin continuous infusion (Drug); reparixin intermittent infusion (Drug); placebo infusion (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dompé Farmaceutici S.p.A
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Creatinine Clearance (CrCl) in the Immediate Post-transplant Period |
5.11; 7.44; 6.30; 9.66; 14.45; 10.75 | 0.9076 |
| SECONDARY Renal Function Tests - Serum Creatinine |
0.686; 0.643; 0.651; 0.683; 0.576; 0.658 | — |
| SECONDARY Renal Function Tests - Calculated Glomerular Filtration Rate |
6.04; 8.03; 7.03; 6.95; 10.68; 8.74 | — |
| SECONDARY Renal Function Tests - Urine Output |
1615.9; 1749.9; 1925.3; 2242.7; 2620.2; 2844.5 | — |
| SECONDARY Number of Patients Requiring Dialysis Within 7 Days Post-transplant |
7; 7; 6; 15; 15; 18 | — |
| SECONDARY Number of Days on Dialysis Before Resuming Kidney Function |
2.5; 1.0; 2.0 | — |
| SECONDARY Number of Patients With Immediate, Slow and Delayed Graft Function |
6; 10; 7; 8; 5; 11 | — |
| SECONDARY Duration of Hospital Stay |
14.6; 16.1; 13.3 | — |
| SECONDARY Mortality |
24; 23; 25; 0; 0; 1 | — |
| SECONDARY Serum Creatinine at Month 1, Month 6 and Month 12 |
0.252; 0.169; 0.186; 0.145; 0.139; 0.179 | — |
| SECONDARY Calculated Serum Creatinine Clearance at Month 1, Month 6 and Month 12 |
42.86; 44.75; 41.21; 52.43; 51.14; 46.93 | — |
| SECONDARY Acute Rejection Episodes at Month 6 and Between Month 6 and Month 12 |
2; 6; 2; 0; 0; 4 | — |
| SECONDARY Patient Survival Rate |
22; 22; 22; 0; 0; 1 | — |
| SECONDARY Graft Survival Rate |
21; 22; 22; 3; 1; 3 | — |
Summary
The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and efficacy of reparixin in preventing the delayed graft function (DGF) after kidney transplantation.
Eligibility Criteria
Inclusion Criteria
- Male and female patients accepted and listed for renal transplantation due to end stage renal disease (ESRD)
- Planned isolated single kidney transplant from a non-living donor with brain death
- Recipients of a kidney maintained in cold storage
- Recipients at risk of developing DGF
- Planned induction with steroids + mycophenolate mofetil (MMF) or mycophenolic acid + biological induction
- Patient willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations
- Patient given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care
Exclusion Criteria
- Recipients of an intended multiple organ transplant
- Recipients of a kidney from a living donor
- Recipients of a kidney from a non-heart beating donor
- Recipients of double kidney transplant
- Re-transplant >2
- Recipients of a kidney maintained by pulsatile machine perfusion
- Concurrent sepsis
- Recipients with hepatic dysfunction at the time of transplant
- Clinical contraindications to central line access, or arteriovenous fistula, if any, not suitable for infusion of investigational product
- Hypersensitivity to non steroidal anti-inflammatory drugs (NSAIDs)
- Patients simultaneously participating in any other clinical trials involving an investigational drug not yet authorized for use in kidney transplant
- Pregnant or breast-feeding women
Data sourced from ClinicalTrials.gov (NCT00248040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.