Renal Transplant RejectionPhase 4NCT00771745
Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients
A Phase 4 study testing Thymoglobulin in people with Renal Transplant Rejection and Transplants and Implants, run by University of Cincinnati at 1 site in United States.
Trial summary
To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Rejection, Transplants and Implants
- What is being tested?
- Thymoglobulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult living donor renal transplant recipient.
- Patient is at least 18 years of age
- If female and of childbearing potential, have a negative serum or urine HCG within 24 hours prior to Study Day -5 (Day of 1st Thymoglobulin dose) and must practice a medically approved method of birth control for the past 30 days prior to enrollment and agree to continue this practice during the 6 month efficacy analysis.
- Signed informed consent.
Who cannot join
- Human Leukocyte Antibody (HLA) identical living donor transplant recipient.
- History of a positive cross-match with the donor.
- Patients with a peak CDC PRA > 50% or a current CDC PRA > 25%.
- Patients who have previously received a kidney transplant.
- Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
- History of noncompliance.
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- History of chronic corticosteroid or immunosuppressive use except for inhaled corticosteroids to treat asthma. .
- Multiple organ transplant recipient.
- Patient with a urinary bladder that is absent or not functional (e.g. self catheterization) pretransplant.
- Patient who does not agree to use effective birth control during the 6-month efficacy analysis.
- Known contraindication to administration of rabbit antithymocyte globulin.
- Initial screening laboratory evaluations will be done locally before renal transplantation and the following laboratory values will be exclusionary: Platelets < 100,000/mm23 or WBC < 3000/mm3
- Currently abusing drugs or alcohol or, in the opinion of the investigator, is at high risk for poor compliance.
- Patient who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states that would preclude participation in the study. Examples of significant problems include, but are not limited to, morbid obesity or severe cardiac disease.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single Center, Pilot Study of Pretransplant Thymoglobulin Administration and Early Corticosteroid Withdrawal in Living Donor Renal Transplant Recipients Under Mycophenolate Mofetil (MMF) and Tacrolimus Immunosuppression
To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.
Read the detailed description
We will evaluate the therapeutic efficacy of administering Thymoglobulin® induction pre-transplantation in renal allograft recipients. Patients receiving pre-transplant Thymoglobulin will be evaluated for acute rejection (Banff '97 criteria), survival, and safety at 6 months. Overall the use of Thymoglobulin induction pre-transplantation will be safe and effective.
- Being tested
- Thymoglobulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymoglobulinDrug
Also called Anti-thymocyte globulin (rabbit), thymoglobulin, rATG
Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF
ThymoglobulinDrug
Also called anti-thymocyte globulin (rabbit), thymoglobulin, rATG
Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF
| Study group | Role | What they receive |
|---|---|---|
| rATG 4 doses | Active comparator | Preloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF Receives: Drug: Thymoglobulin |
| rATG 3 doses | Active comparator | Preloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF Receives: Drug: Thymoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite End Point of Acute Rejection, Graft Loss or Patient Death
Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death
Measured: 6 months
Secondary outcomes (6)
Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.
Measured: Ongoing
Incidence of Infections
Measured: Not defined
Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection
Measured: Not defined
Severity of Biopsy-proven Rejection Using Banff 97 Criteria
Measured: Not defined
Serum Creatinine
Measured: Post-operative days 1-7, 30, 90 and 6 months
Malignancy
Measured: Undefined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2010
- Study completionJul 2010
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.
- Other trials for Renal Transplant RejectionStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Principal investigator, E. Steve Woodle, University of Cincinnati
- Investigators
- E. Steve Woodle, MD, Principal investigator, University of CincinnatiAdele Rike, PharmD, Principal investigator, The Christ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771745
- Sponsor's protocol ID
- Pre-Tx Thymo
- Status last verified
- Dec 2015
- First submitted
- 10 Oct 2008
- Last updated
- 18 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Center, Pilot Study of Pretransplant Thymoglobulin Administration and Early Corticosteroid Withdrawal in Living Donor Renal Transplant Recipients Under Mycophenolate Mofetil (MMF) and Tacrolimus Immunosuppression
- ClinicalTrials.gov ID
- NCT00771745
- Acronym / sponsor ID
- Pre-Tx Thymo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Sep 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Posted 23 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine how safe and effective giving Thymoglobulin before transplantation to patients who are going to be receiving kidney transplants.
Detailed description
We will evaluate the therapeutic efficacy of administering Thymoglobulin® induction pre-transplantation in renal allograft recipients. Patients receiving pre-transplant Thymoglobulin will be evaluated for acute rejection (Banff '97 criteria), survival, and safety at 6 months. Overall the use of Thymoglobulin induction pre-transplantation will be safe and effective.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rATG 4 doses | Active comparator | Drug: ThymoglobulinPreloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF |
| rATG 3 doses | Active comparator | Drug: ThymoglobulinPreloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult living donor renal transplant recipient.
- Patient is at least 18 years of age
- If female and of childbearing potential, have a negative serum or urine HCG within 24 hours prior to Study Day -5 (Day of 1st Thymoglobulin dose) and must practice a medically approved method of birth control for the past 30 days prior to enrollment and agree to continue this practice during the 6 month efficacy analysis.
- Signed informed consent.
Key exclusion criteria (15 listed)
- Human Leukocyte Antibody (HLA) identical living donor transplant recipient.
- History of a positive cross-match with the donor.
- Patients with a peak CDC PRA > 50% or a current CDC PRA > 25%.
- Patients who have previously received a kidney transplant.
- Active donor or recipient serology positive for human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV).
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 |
|---|---|---|
| ThymoglobulinAlso: Anti-thymocyte globulin (rabbit), thymoglobulin, rATGPreloading Induction with Thymoglobulin® X 4 doses given day -4, day -2, day 0, and day 2 at 1.5 mg/kg/dose + corticosteroid taper + tacrolimus + MMF | Drug | rATG 4 doses |
| ThymoglobulinAlso: anti-thymocyte globulin (rabbit), thymoglobulin, rATGPreloading Induction with Thymoglobulin® X 3 doses given day -4 (1.5mg/kg), day -2 (1.5mg/kg), and day 0 (3mg/kg) + corticosteroid taper + tacrolimus + MMF | Drug | rATG 3 doses |
Primary outcome
Composite End Point of Acute Rejection, Graft Loss or Patient Death
Time frame: 6 months
Proportion of Patients Meeting the Composite End Point of Acute Rejection, Graft loss or Patient death
6 secondary outcomes
Incidence of Treatment Failures: Defined as the Percentage of Patients That do Not Remain on Initial Therapy.
Time frame: Ongoing
Incidence of Infections
Time frame: Not defined
Need for Antilymphocyte Antibody Therapy to Treat Acute Rejection
Time frame: Not defined
Severity of Biopsy-proven Rejection Using Banff 97 Criteria
Time frame: Not defined
Serum Creatinine
Time frame: Post-operative days 1-7, 30, 90 and 6 months
Malignancy
Time frame: Undefined
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
E. Steve Woodle, MD principal investigator
University of Cincinnati
Adele Rike, PharmD principal investigator
The Christ Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thymoglobulin in people with Renal Transplant Rejection and Transplants and Implants, run by University of Cincinnati 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 15 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 18 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2015). 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?
Composite End Point of Acute Rejection, Graft Loss or Patient Death (time frame: 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 18 Jan 2016.