Kidney DiseasesNCT00407160
A Trial of Tolerogenic Immunosuppression in Highly Sensitized Renal Transplant Recipients
An observational study of Kidney Diseases, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Diseases
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jan 2011
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end stage renal disease , on dialysis, who are regarded as "high immunological risk" becuase they have lost previous transplants to rejection, or have a high panel reactive antibody (PRA).
Who may be able to join
- Males and females aged 18-75 years.
- Recipients of multiple kidney transplants
- Patients with a PRA >14% and/or a past historical PRA greater or equal to 50%.
- Females of childbearing potential must have a negative pregnancy test prior to inclusion.
- Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Who cannot join
- Patients with a history of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation,confirmed by a positive human chorionic gonadotropin(hCG) laboratory test.
- Patients who are HIV positive.
- Patients with symptoms of significant somatic or mental illness or evidence of current drug and/or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555-0533
About this study
Official title: Comparison of Two Different Immunosuppression Protocols in Highly Sensitized Renal Transplant Recipients: Campath Induction With Tacrolimus Monotherapy vs Thymoglobulin Induction With Triple Drug Protocol.
Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids.
Read the detailed description
Recent reports suggest that it might be possible to induce a state of tolerance in solid organ transplantation. So called "tolerogenic immunosuppression" involves induction with lymphocyte depleting antibodies followed by monotherapy with calcineurin inhibitors, cyclosporin or tacrolimus. The proposed study aims to evaluate a protocol of immunosuppression induction with lymphocyte depleting antibody Campath given prior to graft reperfusion, followed by tacrolimus monotherapy in highly sensitized patients (PRA >14% or past historical =/>50% and/or multiple renal transplants) undergoing renal transplantation, and compare it with the current standard protocol at UTMB which employs induction with Thymoglobulin given over 4 days followed by 3 drugs: tacrolimus, mycophenolate and steroids. In both groups of patients the target tacrolimus levels will be the same i.e, between 10 to 15ng/mL, soon after the transplant. In the Campath gro up, tacrolimus will be tapered after 3 months in patients who do not have rejection and appear to be developing donor specific tolerance.
- Conditions
- Kidney Diseases
- Keywords
- Kidney transplant, Tolerance induction, High Panel Reactive Antibody (PRA) kidney recipients
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Standard Immunosuppression | Anti-thymocyte Globulin (Rabbit)] ,tacrolimus, mycophenolate mofetil and prednisone Patients with End Stage Renal Disease (ESRD) and high Panel Reactive Antibody (PRA) who randomize to the control group. These patients will get induction therapy prior to transplant with Thymoglobulin 1.5 mg/kg/day for 4 days to a total dose of 6mg/kg. They will receive maintenance immunosuppression with three drugs : tacrolimus, cellcept and prednisone. | |
| Group 2 Campath Immunosuppression | Alemtuzumab,tacrolimus Patients with ESRD and high PRA who randomize to the study group. These patients will get induction therapy prior to reperfusion of the kidney, during the transplant operation, with Campath (Alemtuzumab) 30mg, one dose. They will receive maintenance immunosuppression with tacrolimus alone (monotherapy). |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft survival
Cumulative graft survival at 1 year
Measured: 1 year
Secondary outcomes (1)
rejection episodes
1 year cumulative freedom from rejection
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startAug 2004
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip G Thomas, MD, Principal investigator, UTMB Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407160
- Sponsor's protocol ID
- 04-245
- Status last verified
- Dec 2012
- First submitted
- 21 Nov 2006
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Calne RY. Prope tolerance: a step in the search for tolerance in the clinic. World J Surg. 2000 Jul;24(7):793-6. doi: 10.1007/s002680010127.
PubMed 10833245Magliocca JF, Knechtle SJ. The evolving role of alemtuzumab (Campath-1H) for immunosuppressive therapy in organ transplantation. Transpl Int. 2006 Sep;19(9):705-14. doi: 10.1111/j.1432-2277.2006.00343.x.
PubMed 16918530Thomas PG, Woodside KJ, Lappin JA, Vaidya S, Rajaraman S, Gugliuzza KK. Alemtuzumab (Campath 1H) induction with tacrolimus monotherapy is safe for high immunological risk renal transplantation. Transplantation. 2007 Jun 15;83(11):1509-12. doi: 10.1097/01.tp.0000263344.53000.a1.
PubMed 17565326
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Immunosuppression Protocols in Highly Sensitized Renal Transplant Recipients: Campath Induction With Tacrolimus Monotherapy vs Thymoglobulin Induction With Triple Drug Protocol.
- ClinicalTrials.gov ID
- NCT00407160
- Acronym / sponsor ID
- 04-245
- Conditions
- Kidney Diseases
- Keywords
- Kidney transplant, Tolerance induction, High Panel Reactive Antibody (PRA) kidney recipients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Dec 2006 (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.
Comparison between Campath induction and monotherapy with Tacrolimus vs Thymoglobulin induction and triple drug maintenance using Tacrolimus, mycophenolate, and steroids.
Detailed description
Recent reports suggest that it might be possible to induce a state of tolerance in solid organ transplantation. So called "tolerogenic immunosuppression" involves induction with lymphocyte depleting antibodies followed by monotherapy with calcineurin inhibitors, cyclosporin or tacrolimus. The proposed study aims to evaluate a protocol of immunosuppression induction with lymphocyte depleting antibody Campath given prior to graft reperfusion, followed by tacrolimus monotherapy in highly sensitized patients (PRA >14% or past historical =/>50% and/or multiple renal transplants) undergoing renal transplantation, and compare it with the current standard protocol at UTMB which employs induction with Thymoglobulin given over 4 days followed by 3 drugs: tacrolimus, mycophenolate and steroids. In both groups of patients the target tacrolimus levels will be the same i.e, between 10 to 15ng/mL, soon after the transplant. In the Campath gro up, tacrolimus will be tapered after 3 months in patients who do not have rejection and appear to be developing donor specific tolerance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Standard Immunosuppression | – | –Anti-thymocyte Globulin (Rabbit)] ,tacrolimus, mycophenolate mofetil and prednisone Patients with End Stage Renal Disease (ESRD) and high Panel Reactive Antibody (PRA) who randomize to the control group. These patients will get induction therapy prior to transplant with Thymoglobulin 1.5 mg/kg/day for 4 days to a total dose of 6mg/kg. They will receive maintenance immunosuppression with three drugs : tacrolimus, cellcept and prednisone. |
| Group 2 Campath Immunosuppression | – | –Alemtuzumab,tacrolimus Patients with ESRD and high PRA who randomize to the study group. These patients will get induction therapy prior to reperfusion of the kidney, during the transplant operation, with Campath (Alemtuzumab) 30mg, one dose. They will receive maintenance immunosuppression with tacrolimus alone (monotherapy). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end stage renal disease , on dialysis, who are regarded as "high immunological risk" becuase they have lost previous transplants to rejection, or have a high panel reactive antibody (PRA).
Key inclusion criteria (5 listed)
- Males and females aged 18-75 years.
- Recipients of multiple kidney transplants
- Patients with a PRA >14% and/or a past historical PRA greater or equal to 50%.
- Females of childbearing potential must have a negative pregnancy test prior to inclusion.
- Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Key exclusion criteria (4 listed)
- Patients with a history of malignancy within the last 5 years, except excised squamous or basal cell carcinoma of the skin.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation,confirmed by a positive human chorionic gonadotropin(hCG) laboratory test.
- Patients who are HIV positive.
- Patients with symptoms of significant somatic or mental illness or evidence of current drug and/or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
graft survival
Time frame: 1 year
Cumulative graft survival at 1 year
1 secondary outcome
rejection episodes
Time frame: 1 year
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 4 Mar 2019.
- Background: PubMed 10833245Calne RY. Prope tolerance: a step in the search for tolerance in the clinic. World J Surg. 2000 Jul;24(7):793-6. doi: 10.1007/s002680010127.
- Background: PubMed 16918530Magliocca JF, Knechtle SJ. The evolving role of alemtuzumab (Campath-1H) for immunosuppressive therapy in organ transplantation. Transpl Int. 2006 Sep;19(9):705-14. doi: 10.1111/j.1432-2277.2006.00343.x.
- Derived from this study: PubMed 17565326Thomas PG, Woodside KJ, Lappin JA, Vaidya S, Rajaraman S, Gugliuzza KK. Alemtuzumab (Campath 1H) induction with tacrolimus monotherapy is safe for high immunological risk renal transplantation. Transplantation. 2007 Jun 15;83(11):1509-12. doi: 10.1097/01.tp.0000263344.53000.a1.
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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.
Philip G Thomas, MD principal investigator
UTMB Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases, run by The University of Texas Medical Branch, Galveston 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 4 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 4 Mar 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. 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?
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?
graft survival (time frame: 1 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 NCT00407160, which also lists 3 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 4 Mar 2019.