Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)
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|ClinicalTrials.gov Identifier: NCT02145182|
Recruitment Status : Completed
First Posted : May 22, 2014
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Delayed Graft Function||Drug: Eculizumab Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multi-center Study of Eculizumab for the Prevention of Delayed Graft Function After Kidney Transplantation in Adult Subjects at Increased Risk of Delayed Graft Function.|
|Actual Study Start Date :||August 21, 2014|
|Actual Primary Completion Date :||November 22, 2016|
|Actual Study Completion Date :||November 22, 2016|
Eculizumab was administered by intravenous (IV) infusion over 25-45 minutes (min) for 2 doses (on the day of transplant then 18-24 hours [h] later).
Eculizumab is a complement component 5 inhibitor.
Other Name: Soliris
Placebo Comparator: Placebo
Placebo was administered by IV infusion over 25-45 min for 2 doses (on the day of transplant then 18-24 h later).
0.9% sodium chloride
- Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant [ Time Frame: First 7 days post transplantation ]Results are reported for the DGF composite endpoint, defined as the occurrence of DGF (dialysis for any reason in the first 7 days post transplantation), graft loss, death, or loss to follow-up (including discontinuation) in the first 7 days post transplantation and for each item of the composite endpoint. Loss to follow-up included withdrawal due to any reason other than death. The sum of the counts in the events that make up the DGF composite may be greater than the composite count, because a participant who experienced multiple events was only counted once in the composite.
- Percentage Of Participants With DGF, Functional DGF, And Immediate Graft Function [ Time Frame: First 7 days post transplantation ]DGF was defined as a requirement for dialysis for any reason in the first 7 days post transplantation; functional DGF was defined as no need for dialysis during the first 7 days post transplantation and either (1) a <70% reduction in serum creatinine during the first 7 days post transplantation, or (2) failure of serum creatinine to decrease by at least 10% daily on 3 consecutive days, both measured during the first 7 days post transplantation. Blood and urine samples were collected, but because the study failed to demonstrate a treatment effect and the program subsequently lost funding, the collected data from the samples could not be analyzed to generate summary level data. As such, the data set for this secondary outcome measure cannot be summarized.
- Percentage Of Participants Who Required Dialysis Post Transplantation [ Time Frame: First 30 days post transplantation ]The need for dialysis was assessed by evaluation of renal function; this included urine volume, blood urea nitrogen, serum creatinine, and, starting on Day 2, the creatinine reduction ratio. Blood and urine samples were collected, but because the study failed to demonstrate a treatment effect and the program subsequently lost funding, the collected data from the samples could not be analyzed to generate summary level data. As such, the data set for this secondary outcome measure cannot be summarized.
- Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Day 28 post transplantation ]The eGFR was calculated by using the Modification of Diet in Renal Disease 7 equation at Day 28 post transplantation. The equation requires serum creatinine, age, ethnicity, gender, blood urea nitrogen, and albumin. The eGFR was calculated retrospectively from participant demographics and laboratory chemistries and is reported in mL/min/square meter (m^2).
- Percentage Of Participants With Rejection-free Graft Survival [ Time Frame: Week 26 and 52 post transplantation ]Graft survival was defined as not having biopsy-proven acute rejection per Banff criteria, graft loss, or participant death. Participants who did not experience graft loss or death were censored at 365 days or the day they withdrew, whichever came first. There were no time-specific protocol mandated biopsies. Kidney biopsy would have been performed for cause at the discretion of the Investigator to assess poor graft function and would have been obtained prior to initiating treatment of suspected allograft rejection. Only summaries of Kaplan-Meier estimates of graft survival at Week 26 (Month 6) and Week 52 (Month 12) are reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145182