End Stage Renal DiseaseNCT00859131
Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists
A study testing Rabbit Antithymocyte globulin and Daclizumab in people with End Stage Renal Disease, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Rabbit Antithymocyte globulin and Daclizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients between 18 and 75 years of age
- Male or female patients who are primary or repeat cadaveric, living unrelated or non- Human leukocyte antigen (HLA) identical living related donor renal transplant recipients
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.
- The patient has given written informed consent to participate in the study
Who cannot join
- Patient has previously received or is receiving an organ transplant other than a kidney.
- Patients who are recipients of a multiple organ transplant.
- Patient has received a primary or re-transplant from an HLA-identical living donor.
- Any positive cross-match.
- Patient is the recipient of a pediatric donor kidney from a pediatric donor aged 8 years or less.
- Patient has received an ABO incompatible donor kidney.
Show all 18Show fewer
- Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive.
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
- Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
- Patients with thrombocytopenia (<75,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
- Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
- Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, daclizumab or corticosteroids.
- Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
- Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
- Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
- Women of childbearing potential must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study.
- Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
- Inability to cooperate or communicate with the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Rabbit Anti-thymocyte Globulin Versus IL2 Receptor Antagonists in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in a Predominantly High Risk Kidney Transplant Population.
The purpose of this study is to evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).
Read the detailed description
A 12 month, prospective, randomized, single center, open-label study to evaluate the safety and efficacy of Rabbit anti-thymocyte globulin versus IL2 receptor antagonists in combination with tacrolimus, corticosteroids and mycophenolate mofetil in a predominantly high risk kidney transplant population.
- Conditions
- End Stage Renal Disease
- Being tested
- Rabbit Antithymocyte globulin, Daclizumab
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabbit Antithymocyte globulinDrug
Also called Thymoglobulin
1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4
DaclizumabDrug
Also called daclizumab, zenapax
1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
| Study group | Role | What they receive |
|---|---|---|
| Thymoglobulin | Active comparator | Subjects receiving Thymoglobulin as induction agent in renal transplantation Receives: Drug: Rabbit Antithymocyte globulin |
| Zenapax | Active comparator | subject who will receive daclizumab or basiliximab as induction agent in renal transplantation Receives: Drug: Daclizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.
Measured: One year
Secondary outcomes (6)
Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.
Measured: One year
Graft Survival at One Year Post-transplant
Measured: One year
Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis
Measured: one year
Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.
Measured: One year
Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3
Measured: One year
Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Kenneth D Chavin, MD,PhD, Study chair, Medical University of South CarolinaNicole Pilch, PharmD, Study chair, Medical University of South CarolinaDavid Taber, PharmD, Study chair, Medical University of South CarolinaPrabhakar Baliga, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859131
- Sponsor's protocol ID
- thymo vs IL2
- Status last verified
- Feb 2014
- First submitted
- 6 Mar 2009
- Last updated
- 26 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Palanisamy AP, Al Manasra AR, Pilch NA, Dowden JE, Nadig SN, McGillicuddy JW, Baliga PK, Chavin KD, Taber DJ. Induction therapy: clinical and quality of life outcomes in aged renal transplant recipients. Clin Transplant. 2015 Mar;29(3):222-6. doi: 10.1111/ctr.12507. Epub 2015 Jan 27.
PubMed 25557762Pilch NA, Taber DJ, Moussa O, Thomas B, Denmark S, Meadows HB, McGillicuddy JW, Srinivas TR, Baliga PK, Chavin KD. Prospective randomized controlled trial of rabbit antithymocyte globulin compared with IL-2 receptor antagonist induction therapy in kidney transplantation. Ann Surg. 2014 May;259(5):888-93. doi: 10.1097/SLA.0000000000000496.
PubMed 24513787
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rabbit Anti-thymocyte Globulin Versus IL2 Receptor Antagonists in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in a Predominantly High Risk Kidney Transplant Population.
- ClinicalTrials.gov ID
- NCT00859131
- Acronym / sponsor ID
- thymo vs IL2
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Mar 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Posted 26 Apr 2016
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 evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).
Detailed description
A 12 month, prospective, randomized, single center, open-label study to evaluate the safety and efficacy of Rabbit anti-thymocyte globulin versus IL2 receptor antagonists in combination with tacrolimus, corticosteroids and mycophenolate mofetil in a predominantly high risk kidney transplant population.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thymoglobulin | Active comparator | Drug: Rabbit Antithymocyte globulinSubjects receiving Thymoglobulin as induction agent in renal transplantation |
| Zenapax | Active comparator | Drug: Daclizumabsubject who will receive daclizumab or basiliximab as induction agent in renal transplantation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients between 18 and 75 years of age
- Male or female patients who are primary or repeat cadaveric, living unrelated or non- Human leukocyte antigen (HLA) identical living related donor renal transplant recipients
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.
- The patient has given written informed consent to participate in the study
Key exclusion criteria (18 listed)
- Patient has previously received or is receiving an organ transplant other than a kidney.
- Patients who are recipients of a multiple organ transplant.
- Patient has received a primary or re-transplant from an HLA-identical living donor.
- Any positive cross-match.
- Patient is the recipient of a pediatric donor kidney from a pediatric donor aged 8 years or less.
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 |
|---|---|---|
| Rabbit Antithymocyte globulinAlso: Thymoglobulin1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4 | Drug | Thymoglobulin |
| DaclizumabAlso: daclizumab, zenapax1.0 mg/kg pre-op and 1.0 mg/kg on Day 7 | Drug | Zenapax |
Primary outcome
Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.
Time frame: One year
6 secondary outcomes
Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.
Time frame: One year
Graft Survival at One Year Post-transplant
Time frame: One year
Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis
Time frame: one year
Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.
Time frame: One year
Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3
Time frame: One year
Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25557762Palanisamy AP, Al Manasra AR, Pilch NA, Dowden JE, Nadig SN, McGillicuddy JW, Baliga PK, Chavin KD, Taber DJ. Induction therapy: clinical and quality of life outcomes in aged renal transplant recipients. Clin Transplant. 2015 Mar;29(3):222-6. doi: 10.1111/ctr.12507. Epub 2015 Jan 27.
- Derived from this study: PubMed 24513787Pilch NA, Taber DJ, Moussa O, Thomas B, Denmark S, Meadows HB, McGillicuddy JW, Srinivas TR, Baliga PK, Chavin KD. Prospective randomized controlled trial of rabbit antithymocyte globulin compared with IL-2 receptor antagonist induction therapy in kidney transplantation. Ann Surg. 2014 May;259(5):888-93. doi: 10.1097/SLA.0000000000000496.
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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.
Kenneth D Chavin, MD,PhD study chair
Medical University of South Carolina
Nicole Pilch, PharmD study chair
Medical University of South Carolina
David Taber, PharmD study chair
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rabbit Antithymocyte globulin and Daclizumab in people with End Stage Renal Disease, run by Medical University of South Carolina 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 4 inclusion and 18 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: finished, as of the sponsor's last update on 26 Apr 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00859131, which also lists 2 linked publications.
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 26 Apr 2016.