Delayed Function of Renal TransplantPhase 2NCT01403389
A Study of the Activity of Eculizumab for Prevention of Delayed Graft Function In Deceased Donor Kidney Transplant
A Phase 2 study testing Eculizumab in people with Delayed Function of Renal Transplant, run by Schroppel, Bernd, M.D. at 1 site in United States.
Trial summary
The purpose of this study is to determine if Eculizumab is safe and effective in the prevention of delayed graft function following deceased donor kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Function of Renal Transplant
- What is being tested?
- Eculizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2011to 6 Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Weight > 40 kg
- Male or Female
- Recipients of first deceased donor kidneys
- Able to provide written informed consent
- Transplant candidate as per site specific guidelines
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- Dialysis dependent renal failure (initiated more than 2 months prior to transplant)
- Novartis Delayed Graft Function Score 3-8
- Extended criteria donor with brain death, or standard criteria donor with cold ischemic time < 24 hours
Who cannot join
- Planned to receive multi-organ transplant
- Kidneys from donors < 6 years of age
- Dual kidney transplant (from same donor, including en bloc)
- Living donor kidney
- Highly sensitized recipients (PRA > 50%)
- Previous transplant
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- Participation in another investigational trial
- Recipient BMI > 40
- ABO incompatible
- DCD Donor
- Preemptive kidney transplant
- Recipients with DGF scores < 3 or > 8
- Women who are pregnant or breast feeding
- Women of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception
- Patients infected with HIV, HCV or HBV
- Active bacterial or other infection which is clinically significant in the opinion of the investigator
- Patients with history of splenectomy
- Patients with history of meningococcal disease
- Patients with known or suspected hereditary complement deficiency
- Patients with history of cancer (other than non-melanoma skin cancers) within the last 5 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Recanati/Miller Transplantation Institute
New York, New York, 10029
About this study
Official title: Pilot Study of the Clinical Activity of Eculizumab for Prevention of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation
The purpose of this study is to determine if Eculizumab is safe and effective in the prevention of delayed graft function following deceased donor kidney transplantation.
Read the detailed description
Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It is further hypothesized that eculizumab, an antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. To test this hypothesis, this study is a pilot prospective, randomized study to test the efficacy of eculizumab vs. placebo given once at the time of transplantation in preventing delayed graft function in first adult recipients of deceased donor kidneys.
- Conditions
- Delayed Function of Renal Transplant
- Being tested
- Eculizumab, Placebo
- Keywords
- Kidney Transplant, Delayed Graft Function
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EculizumabDrug
Also called Soliris
1200 milligrams Eculizumab diluted in 0.9% NaCl to 5mg/mL for a total volume of 240 mL administered by IV infusion over 35 minutes in the operating room prior to organ reperfusion
PlaceboDrug
Also called 0.9% Sodium Chloride
240 mL of 0.9% Sodium Chloride IV fluid given as placebo in the operating room prior to organ reperfusion
| Study group | Role | What they receive |
|---|---|---|
| Eculizumab | Experimental | Not described Receives: Drug: Eculizumab |
| 0.9% Sodium Chloride | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Delayed Graft Function and Slow Graft Function
Delayed Graft Function defined as follows:
- A need for at least one dialysis treatment during the first 7 days after transplantation (not including a single session for hyperkalemia or hypervolemia in the first 48 hours)
- A less than or equal to 50% reduction in serum creatinine in the first 24 hours post-transplantation
- A serum creatinine reduction ratio < 30% at 48 hours post-transplantation
Slow Graft Function Defined as Follows:
A functioning graft at Day 5 Post-transplantation with a serum creatinine > 3 mg/dL and no need for dialysis
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study start1 Dec 2011
- Primary completion6 Aug 2013
- Study completion6 Feb 2014
Why it stopped: After interim analysis, the pilot study was terminated and modified to a larger multicenter study (NCT01919346) to better assess efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Function of Renal TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schroppel, Bernd, M.D.
- Collaborators
- Alexion Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Bernd Schroppel, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403389
- Sponsor's protocol ID
- HSM 10-1600
- Status last verified
- May 2019
- First submitted
- 25 Jul 2011
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Clinical Activity of Eculizumab for Prevention of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01403389
- Acronym / sponsor ID
- HSM 10-1600
- Conditions
- Delayed Function of Renal Transplant
- Keywords
- Kidney Transplant, Delayed Graft Function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After interim analysis, the pilot study was terminated and modified to a larger multicenter study (NCT01919346) to better assess efficacy.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Schroppel, Bernd, M.D.
- Collaborators
- Alexion Pharmaceuticals, Inc.
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 6 Aug 2013 (actual)
- Study completion
- 6 Feb 2014 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Eculizumab is safe and effective in the prevention of delayed graft function following deceased donor kidney transplantation.
Detailed description
Based on experimental data and supportive observations in humans associating complement gene upregulation with ischemic reperfusion injury, it is hypothesized that C5 cleavage is a key step in the pathogenesis of ischemic reperfusion injury following transplantation. It is further hypothesized that eculizumab, an antibody that blocks C5 cleavage in humans will be an effective prophylactic agent to prevent ischemic reperfusion injury in high risk recipients. To test this hypothesis, this study is a pilot prospective, randomized study to test the efficacy of eculizumab vs. placebo given once at the time of transplantation in preventing delayed graft function in first adult recipients of deceased donor kidneys.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eculizumab | Experimental | Drug: Eculizumab |
| 0.9% Sodium Chloride | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or older
- Weight > 40 kg
- Male or Female
- Recipients of first deceased donor kidneys
- Able to provide written informed consent
Key exclusion criteria (20 listed)
- Planned to receive multi-organ transplant
- Kidneys from donors < 6 years of age
- Dual kidney transplant (from same donor, including en bloc)
- Living donor kidney
- Highly sensitized recipients (PRA > 50%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EculizumabAlso: Soliris1200 milligrams Eculizumab diluted in 0.9% NaCl to 5mg/mL for a total volume of 240 mL administered by IV infusion over 35 minutes in the operating room prior to organ reperfusion | Drug | Eculizumab |
| PlaceboAlso: 0.9% Sodium Chloride240 mL of 0.9% Sodium Chloride IV fluid given as placebo in the operating room prior to organ reperfusion | Drug | 0.9% Sodium Chloride |
Primary outcome
Composite of Delayed Graft Function and Slow Graft Function
Time frame: Up to 6 months
Delayed Graft Function defined as follows: 1. A need for at least one dialysis treatment during the first 7 days after transplantation (not including a single session for hyperkalemia or hypervolemia in the first 48 hours) 2. A less than or equal to 50% reduction in serum creatinine in the first 24 hours post-transplantation 3. A serum creatinine reduction ratio < 30% at 48 hours post-transplantation Slow Graft Function Defined as Follows: A functioning graft at Day 5 Post-transplantation with a serum creatinine > 3 mg/dL and no need for dialysis
Results and safety
The study was stopped early (reason given: After interim analysis, the pilot study was terminated and modified to a larger multicenter study (NCT01919346) to better assess efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
Related trials for Delayed Function of Renal Transplant
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Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation
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Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation
Delayed Graft Function, DGF
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Microvasculature Ultrasound Super-resolution in Transplant Delayed Graft Function
End Stage Chronic Renal Failure, Renal Transplant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Schroppel, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eculizumab in people with Delayed Function of Renal Transplant, run by Schroppel, Bernd, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: After interim analysis, the pilot study was terminated and modified to a larger multicenter study (NCT01919346) to better assess efficacy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Delayed Graft Function and Slow Graft Function (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.