A Phase 2/3 interventional study of Eculizumab and Placebo in Delayed Graft Function, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 78 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-17.
Sponsored by Alexion Pharmaceuticals, Inc. (part of AstraZeneca) · Phase 2/3, Interventional, and Prevention
The purpose of this study was to determine if eculizumab is safe and could be used to prevent delayed graft function (DGF) following kidney transplantation.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's enrollment of 288 is above the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →Alexion Pharmaceuticals, Inc. is the lead sponsor of 255 studies on the registry; 23 are open to participants now.
Of its 101 completed or terminated interventional studies of FDA-regulated products, 75 (74%) have results posted.
First submitted before Alexion Pharmaceuticals, Inc. became part of AstraZeneca.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: Eculizumab
Placebo was administered by IV infusion over 25-45 min for 2 doses (on the day of transplant then 18-24 h later).
Drug: Placebo
Eculizumab is a complement component 5 inhibitor.
Also known as: Soliris
0.9% sodium chloride
Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant
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.
Time frame: First 7 days post transplantation
Percentage Of Participants With DGF, Functional DGF, And Immediate Graft Function
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.
Time frame: First 7 days post transplantation
Percentage Of Participants Who Required Dialysis 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.
Time frame: First 30 days post transplantation
Estimated Glomerular Filtration Rate (eGFR)
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).
Time frame: Day 28 post transplantation
Percentage Of Participants With Rejection-free Graft Survival
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.
Time frame: Week 26 and 52 post transplantation
Fifty-nine centers in Australia, Brazil, Canada, Czech Republic, France, Germany, Italy, Spain, and the United States of America participated in this study. The study recruited participants who had been receiving dialysis for a median of approximately 50 months before undergoing transplantation and received a kidney from a deceased donor.
| Milestone | Eculizumab | Placebo |
|---|---|---|
| Started | 142 | 146 |
| Received at least 1 dose of study drug | 142 | 146 |
| Completed | 124 | 130 |
| Not completed | 18 | 16 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Death | 7 | 7 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Pre-transplant withdrawal | 0 | 2 |
| Withdrew: Withdrawal by subject | 5 | 4 |
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 | Eculizumab | Placebo |
|---|---|---|
| DGF Composite | 35.9 | 41.7 |
| DGF | 33.8 | 39.6 |
| Death | 0.0 | 1.4 |
| Graft Loss | 0.7 | 3.5 |
| Lost to Follow-up (including discontinuation) | 3.5 | 1.4 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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).
| mL/min/1.73 m^2 | Eculizumab | Placebo |
|---|---|---|
| Estimated Glomerular Filtration Rate (eGFR) | 42.640 ± 20.7491 | 39.954 ± 20.3288 |
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.
| percentage of participants | Eculizumab | Placebo |
|---|---|---|
| Graft Survival at Month 6 | 94.89 (89.58 to 97.53) | 90.96 (84.94 to 94.65) |
| Graft Survival at Month 12 | 92.66 (86.78 to 95.98) | 88.69 (82.17 to 92.92) |
Collected over Non-serious adverse events were required to be reported during the study up to 60 days after the last dose of study drug and serious adverse events were required to be reported during the study through 12 months of follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Eculizumab | 8/142 (5.6%) | 92/142 (64.8%) | 139/142 (97.9%) |
| Placebo | 7/146 (4.8%) | 102/146 (69.9%) | 142/146 (97.3%) |
| Event | Eculizumab | Placebo |
|---|---|---|
| HyperkalaemiaMetabolism and nutrition disorders | 9/142 | 5/146 |
| PneumoniaInfections and infestations | 7/142 | 8/146 |
| Urinary tract infectionInfections and infestations | 7/142 | 4/146 |
| Deep vein thrombosisVascular disorders | 1/142 | 7/146 |
| UrosepsisInfections and infestations | 6/142 | 3/146 |
| Acute kidney injuryRenal and urinary disorders | 3/142 | 6/146 |
| AnaemiaBlood and lymphatic system disorders | 5/142 | 3/146 |
| PyrexiaGeneral disorders | 4/142 | 4/146 |
| Kidney transplant rejectionImmune system disorders | 4/142 | 3/146 |
| Septic shockInfections and infestations | 4/142 | 1/146 |
| Event | Eculizumab | Placebo |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 77/142 | 75/146 |
| HyperkalaemiaMetabolism and nutrition disorders | 59/142 | 67/146 |
| Oedema peripheralGeneral disorders | 41/142 | 57/146 |
| ConstipationGastrointestinal disorders | 40/142 | 40/146 |
| HypomagnesaemiaMetabolism and nutrition disorders | 40/142 | 28/146 |
| HypertensionVascular disorders | 34/142 | 39/146 |
| LeukopeniaBlood and lymphatic system disorders | 37/142 | 30/146 |
| DiarrhoeaGastrointestinal disorders | 37/142 | 35/146 |
| NauseaGastrointestinal disorders | 36/142 | 32/146 |
| AcidosisMetabolism and nutrition disorders | 35/142 | 24/146 |
Safety Set: all participants who received at least 1 dose of study drug (placebo or eculizumab).
| Age, Continuous(years) | Eculizumab | Placebo | Total |
|---|---|---|---|
| Mean | 57.5 ± 12.29 | 57.1 ± 13.03 | 57.3 ± 12.65 |
| Sex: Female, Male(Participants) | Eculizumab | Placebo | Total |
|---|---|---|---|
| Female | 47 | 45 | 92 |
| Male | 95 | 101 | 196 |
| Ethnicity (NIH/OMB)(Participants) | Eculizumab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 23 | 23 | 46 |
| Not Hispanic or Latino | 108 | 113 | 221 |
| Unknown or Not Reported | 11 | 10 | 21 |
| Race/Ethnicity, Customized(Participants) | Eculizumab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaskan Native | 1 | 2 | 3 |
| Asian | 0 | 4 | 4 |
| Black or African American | 38 | 37 | 75 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| White | 88 | 92 | 180 |
| Other | 9 | 7 | 16 |
| Multiple | 1 | 1 | 2 |
| Unknown | 4 | 3 | 7 |
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Eculizumab
Alexion Pharmaceuticals, Inc. →