End-Stage Renal DiseasePhase 4NCT01046955
Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation
A Phase 4 study testing Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab in people with End-Stage Renal Disease and Living Donors, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to observe in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with the investigators standard treatment protocol of Zenapax® and maintenance immunosuppression. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- End-Stage Renal Disease, Living Donors
- What is being tested?
- Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Dec 2008
- Phase
- Phase 4
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >14 years
- Weight >40 kg
- Primary renal allograft:living related (non HLA identical) and unrelated donor
- Negative standard cross match for T-cells
- Signed and dated consent form
Who cannot join
- Patient has previously received or is receiving an organ transplant other than kidney
- Patient has received a kidney transplant from a non-heart beating donor
- Patient has received an ABO incompatible donor kidney
- Recipient or donor is seropositive for human immunodeficiency virus (HIV)
- Patient has a current malignancy or a history of malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Jackson Memorial Hospital
Miami, Florida, 33136
About this study
Official title: Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-term Nephrotoxic Calcineurin Inhibitor Therapy
The purpose of this study is to observe in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with the investigators standard treatment protocol of Zenapax® and maintenance immunosuppression.
Read the detailed description
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with our standard treatment protocol of Zenapax® and maintenance immunosuppression (vide infra).
To determine the effect different antibody induction regimen on the lymphoid cell subsets of the immune system in kidney allograft recipients peripheral blood and bone marrow aspirates will be tested at surgery before transplantation and at intervals post operatively.
To treat renal transplant patients successfully in the absence of long-term calcineurin inhibition to determine if there are beneficial effects on the prevention of chronic allograft nephropathy.
- Conditions
- End-Stage Renal Disease, Living Donors
- Being tested
- Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
- Keywords
- ESRD
- 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.
Anti-Thymocyte Globulin vs Campath-1H vs DaclizumabDrug
Also called Thymoglobulin, Zenapax
comparison of induction therapies.
| Study group | Role | What they receive |
|---|---|---|
| 1mg/kg Thymoglobulin | Active comparator | LD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery. Receives: Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab |
| Campath-1H at 0.3 mg/kg | Active comparator | Recipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively. Receives: Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab |
| Zenapax 1 mg/kg | Active comparator | Recipients of LD kidneys receiving Zenapax 1mg/kg on the day of surgery followed by the same dose every 2 weeks for a total of 5 dosages. Receives: Drug: Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys.
Measured: 3 years
Patient/graft survival.
Measured: 1 and 3 yrs.
Secondary outcomes (1)
Incidence of adverse reactions.
Measured: 1 & 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startNov 2005
- Primary completionApr 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- George W Burke, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046955
- Sponsor's protocol ID
- 20010704
- Status last verified
- May 2008
- First submitted
- 11 Jan 2010
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-term Nephrotoxic Calcineurin Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT01046955
- Acronym / sponsor ID
- 20010704
- Conditions
- End-Stage Renal Disease, Living Donors
- Keywords
- ESRD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Nov 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Jan 2010 (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 observe in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with the investigators standard treatment protocol of Zenapax® and maintenance immunosuppression.
Detailed description
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with our standard treatment protocol of Zenapax® and maintenance immunosuppression (vide infra).
To determine the effect different antibody induction regimen on the lymphoid cell subsets of the immune system in kidney allograft recipients peripheral blood and bone marrow aspirates will be tested at surgery before transplantation and at intervals post operatively.
To treat renal transplant patients successfully in the absence of long-term calcineurin inhibition to determine if there are beneficial effects on the prevention of chronic allograft nephropathy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1mg/kg Thymoglobulin | Active comparator | Drug: Anti-Thymocyte Globulin vs Campath-1H vs DaclizumabLD kidneys receiving 1mg/kg Thymoglobulin for 7 days starting at the day of surgery. |
| Campath-1H at 0.3 mg/kg | Active comparator | Drug: Anti-Thymocyte Globulin vs Campath-1H vs DaclizumabRecipients of LD kidneys receiving Campath-1H at 0.3 mg/kg once on the day of surgery and again 3 days post-operatively. |
| Zenapax 1 mg/kg | Active comparator | Drug: Anti-Thymocyte Globulin vs Campath-1H vs DaclizumabRecipients of LD kidneys receiving Zenapax 1mg/kg on the day of surgery followed by the same dose every 2 weeks for a total of 5 dosages. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age >14 years
- Weight >40 kg
- Primary renal allograft:living related (non HLA identical) and unrelated donor
- Negative standard cross match for T-cells
- Signed and dated consent form
Key exclusion criteria (5 listed)
- Patient has previously received or is receiving an organ transplant other than kidney
- Patient has received a kidney transplant from a non-heart beating donor
- Patient has received an ABO incompatible donor kidney
- Recipient or donor is seropositive for human immunodeficiency virus (HIV)
- Patient has a current malignancy or a history of malignancy
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 |
|---|---|---|
| Anti-Thymocyte Globulin vs Campath-1H vs DaclizumabAlso: Thymoglobulin, Zenapaxcomparison of induction therapies. | Drug | 1mg/kg Thymoglobulin, Campath-1H at 0.3 mg/kg, Zenapax 1 mg/kg |
Primary outcome
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys.
Time frame: 3 years
Patient/graft survival.
Time frame: 1 and 3 yrs.
1 secondary outcome
Incidence of adverse reactions.
Time frame: 1 & 3 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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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.
George W Burke, M.D. principal investigator
University of Miami
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 Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab in people with End-Stage Renal Disease and Living Donors, run by University of Miami 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 5 inclusion and 5 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 12 Jan 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys. (time frame: 3 years). The study lists 2 primary outcomes in all. 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 12 Jan 2010.