Living-Donor Kidney TransplantPhase 4NCT00681343
Thymoglobulin Versus Campath-1H Versus Daclizumab in Adult, Primary Living Donor Renal Transplantation
A Phase 4 study testing Thymoglobulin, Campath-1H and Daclizumab in people with Living-Donor Kidney Transplant, run by University of Miami at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Living-Donor Kidney Transplant
- What is being tested?
- Thymoglobulin, Campath-1H and Daclizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Oct 2007
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has been fully informed and has signed a dated IRB approval informed consent form and is willing to follow study procedures for the extent of the study (36 months). Parent or legal guardian must provide written consent for patients <18 years of age.
- Age 16-65 years
- Weight > 40 kg
- Primary renal allograft: living related (non HLA identical) and unrelated donor
- Negative standard cross-match for T-cells. All donor-recipient pairs matched for a minimum of 1 HLA DR antigen. (Standard at our center)
- Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception for 3 months following discontinuation of Thymoglobulin or Campath-1H
- Males and females are to be studied equivalently as they become available for transplantation using these criteria.
Who cannot join
- Patient has previously received or is receiving an organ transplant other than a kidney.
- Patient is receiving an ABO incompatible donor kidney.
- Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or carcinoma in situ of the cervix that has been treated successfully.
- Patients with significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of this center.
- Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
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- Patient is currently participating in another clinical trial of an investigational drug in the 30 days prior to transplant.
- Patient will be receiving any immunosuppressive agent other that those prescribed in the study.
- Patient is unable to take medications orally or via nasogastric tube by the morning of the second day following completion of the transplant procedure (i.e. skin closure).
- Patient is receiving or may require warfarin, fluvastatin or herbal supplements during the study.
- Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.
- Patient has a known hypersensitivity to Tacrolimus, Campath-1H, Thymoglobulin, Daclizumab (Zenapax®), Sirolimus, MMF or corticosteroids.
- Patient is pregnant or lactating.
- Patients with a screening/baseline (or within 96 hours of transplant) total white blood cell count <4000/mm3; platelet count <100,000/mm3; fasting triglycerides >400 mg/dl (>4.6 mmol/L); fasting total cholesterol >300 mg/dl (>7.8 mmol/L); fasting HDL-cholesterol <30 mg/dl; fasting LDL-cholesterol >200mg/dl.
- Patient is unlikely to comply with the visits scheduled in the protocol.
- Patient has any form of substance abuse, psychiatric disorder or a condition that, in opinion of the investigator, may invalidate communication with the investigator.
- If tacrolimus cannot be instituted for longer than 5 days postoperatively.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Division of Transplantation
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
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
- Conditions
- Living-Donor Kidney Transplant
- Being tested
- Thymoglobulin, Campath-1H, Daclizumab
- Keywords
- Randomized, study, effectiveness/toxicity, induction therapy, recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymoglobulinDrug
Induction
Campath-1HDrug
Also called Alemtuzumab
Induction
DaclizumabDrug
Also called Zenapax
Induction
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Thymoglobulin Induction Receives: Drug: Thymoglobulin |
| B | Experimental | Campath-1H Induction Receives: Drug: Campath-1H |
| C | Experimental | Daclizumab Induction Receives: Drug: Daclizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of biopsy-proven acute rejection at 1 year.
Measured: 1 year
Secondary outcomes (4)
Patient and graft survival
Measured: 1 and 3 years
Incidence of biopsy-proven chronic allograft nephropathy.
Measured: 1 and 3 years
Levels of lymphoid cell subsets.
Measured: 1 and 3 years
Incidence of adverse reactions, for example: Infections, Malignancies, Thromboembolic events.
Measured: 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startSep 2002
- Primary completionOct 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Living-Donor Kidney TransplantStudies 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
- Primary purpose
- Treatment
- 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, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681343
- Sponsor's protocol ID
- IRB#20010704
- Status last verified
- Sep 2023
- First submitted
- 19 May 2008
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ciancio G, Gaynor JJ, Guerra G, Sageshima J, Chen L, Mattiazzi A, Roth D, Kupin W, Tueros L, Flores S, Hanson L, Vianna R, Burke GW 3rd. Randomized trial of three induction antibodies in kidney transplantation: long-term results. Transplantation. 2014 Jun 15;97(11):1128-38. doi: 10.1097/01.TP.0000441089.39840.66.
PubMed 24477186
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. 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
- NCT00681343
- Acronym / sponsor ID
- IRB#20010704
- Conditions
- Living-Donor Kidney Transplant
- Keywords
- Randomized, study, effectiveness/toxicity, induction therapy, recipients
- 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
- Sep 2002
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 21 May 2008 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ThymoglobulinThymoglobulin Induction |
| B | Experimental | Drug: Campath-1HCampath-1H Induction |
| C | Experimental | Drug: DaclizumabDaclizumab Induction |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has been fully informed and has signed a dated IRB approval informed consent form and is willing to follow study procedures for the extent of the study (36 months). Parent or legal guardian must provide written consent for patients <18 years of age.
- Age 16-65 years
- Weight > 40 kg
- Primary renal allograft: living related (non HLA identical) and unrelated donor
- Negative standard cross-match for T-cells. All donor-recipient pairs matched for a minimum of 1 HLA DR antigen. (Standard at our center)
Key exclusion criteria (17 listed)
- Patient has previously received or is receiving an organ transplant other than a kidney.
- Patient is receiving an ABO incompatible donor kidney.
- Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or carcinoma in situ of the cervix that has been treated successfully.
- Patients with significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of this center.
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 |
|---|---|---|
| ThymoglobulinInduction | Drug | A |
| Campath-1HAlso: AlemtuzumabInduction | Drug | B |
| DaclizumabAlso: ZenapaxInduction | Drug | C |
Primary outcome
Incidence and severity of biopsy-proven acute rejection at 1 year.
Time frame: 1 year
4 secondary outcomes
Patient and graft survival
Time frame: 1 and 3 years
Incidence of biopsy-proven chronic allograft nephropathy.
Time frame: 1 and 3 years
Levels of lymphoid cell subsets.
Time frame: 1 and 3 years
Incidence of adverse reactions, for example: Infections, Malignancies, Thromboembolic events.
Time frame: 1 and 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 14 Sep 2023.
- Derived from this study: PubMed 24477186Ciancio G, Gaynor JJ, Guerra G, Sageshima J, Chen L, Mattiazzi A, Roth D, Kupin W, Tueros L, Flores S, Hanson L, Vianna R, Burke GW 3rd. Randomized trial of three induction antibodies in kidney transplantation: long-term results. Transplantation. 2014 Jun 15;97(11):1128-38. doi: 10.1097/01.TP.0000441089.39840.66.
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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 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 Thymoglobulin, Campath-1H and Daclizumab in people with Living-Donor Kidney Transplant, 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 7 inclusion and 17 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 14 Sep 2023. 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?
Incidence and severity of biopsy-proven acute rejection at 1 year. (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 NCT00681343, which also lists 1 linked publication.
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 14 Sep 2023.