DiabetesPhase 4NCT00706680
Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol
A Phase 4 study testing Thymoglobulin in people with Diabetes and Graft Rejection, run by University Health Network, Toronto at 3 sites in Canada.
Trial summary
This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine and early steroid dosage reduction will minimize both kidney rejection and the development of new onset diabetes mellitus after renal transplant. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Graft Rejection
- What is being tested?
- Thymoglobulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2008to Jun 2009
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- De Novo, single Kidney recipient
- At least 1 HLA mismatch
Who cannot join
- Recipient of multiple organs
- prior transplant recipient
- Subjects who have Diabetes prior to transplant, as indicated by pre-transplant OGTT
- PRA >10%
- Hepatitis B surface antigen positive
- Hepatitis C antibody positive
- HIV positive
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Not yet recruiting
St Michael's Hospital
Toronto, Ontario, M5C 2T2
Ramesh Prasad, (416) 867-3722, Ramesh.Prasad@utoronto.ca
Ramesh Prasad
- Recruiting
University health Network
Toronto, Ontario, M5G 2N2
Bricio Rodriguez, 416-340-4800 ext. 5921, bricio.rodriguez@uhn.on.ca
Carl Cardella
- Not yet recruiting
St Paul's Hospital
Vancouver, British Columbia, V6Z 2E8
John Gill, 604-681-7191
John Gill
About this study
Official title: The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol
This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine and early steroid dosage reduction will minimize both kidney rejection and the development of new onset diabetes mellitus after renal transplant.
Read the detailed description
All patients will receive methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin will be initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation in all patients and a total dose of 6-7.5mg/kg will be given over 3-5 doses. Steroids will be initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days and then patients will be placed on 5mg daily for the remainder of the study. All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed. Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target of 600-800 nanograms/ml.
- Conditions
- Diabetes, Graft Rejection
- Being tested
- Thymoglobulin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymoglobulinDrug
Also called Thymo, Polyclonal ATG, Methyl Prednisone, SoluMedrol
methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin, initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation for a total dose of 6-7.5mg/kg given over 3-5 doses. Steroids initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days. Patients will be placed on 5mg daily for the remainder of the study. All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed. Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target of 600-800 nanograms/ml.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects meeting the entry criteria will be treated with the study immunosuppressive protocol. Receives: Drug: Thymoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test
Measured: 6 months post transplant.
Secondary outcomes (1)
Incidence of acute rejection
Measured: 6 months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2009 (estimated)
- Study completionJun 2009 (estimated)
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 DiabetesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Unity Health Toronto, St. Paul's Hospital, Canada
- Investigators
- Edward Cole, Study director, University Health Network, TorontoJohn Gill, Principal investigator, St. Paul's HospitalRamesh Prasad, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706680
- Sponsor's protocol ID
- 07-0619-A
- Status last verified
- Feb 2008
- First submitted
- 8 Feb 2008
- Last updated
- 27 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Cole EH, Prasad GV, Cardella CJ, Kim JS, Tinckam KJ, Cattran DC, Schiff JR, Landsberg DN, Zaltzman JS, Gill JS. A pilot study of reduced dose cyclosporine and corticosteroids to reduce new onset diabetes mellitus and acute rejection in kidney transplant recipients. Transplant Res. 2013 Jan 12;2(1):1. doi: 10.1186/2047-1440-2-1.
PubMed 23369458
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Thymoglobulin in a Calcineurin Inhibitor and Steroid Minimization Protocol
- ClinicalTrials.gov ID
- NCT00706680
- Acronym / sponsor ID
- 07-0619-A
- Conditions
- Diabetes, Graft Rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, Unity Health Toronto, St. Paul's Hospital, Canada
- Study start
- Feb 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 27 Jun 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.
This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine and early steroid dosage reduction will minimize both kidney rejection and the development of new onset diabetes mellitus after renal transplant.
Detailed description
All patients will receive methyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin will be initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation in all patients and a total dose of 6-7.5mg/kg will be given over 3-5 doses. Steroids will be initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days and then patients will be placed on 5mg daily for the remainder of the study. All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed. Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target of 600-800 nanograms/ml.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ThymoglobulinAll subjects meeting the entry criteria will be treated with the study immunosuppressive protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- De Novo, single Kidney recipient
- At least 1 HLA mismatch
Key exclusion criteria (7 listed)
- Recipient of multiple organs
- prior transplant recipient
- Subjects who have Diabetes prior to transplant, as indicated by pre-transplant OGTT
- PRA >10%
- Hepatitis B surface antigen positive
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: Thymo, Polyclonal ATG, Methyl Prednisone, SoluMedrolmethyl prednisone intravenously pre-operatively, as per institutional practice. Thymoglobulin, initiated prior to completion of the anastomosis, or if not possible, within 24 hours of transplantation for a total dose of 6-7.5mg/kg given over 3-5 doses. Steroids initiated post-operatively at 1mg/kg/day for 2 days, then 0.5mg/kg/day for 2 days, then 0.25mg/kg/day for 2 days. Patients will be placed on 5mg daily for the remainder of the study. All patients will receive Mycophenolic acid at a dose of 2gm/day (Cellcept) or 1440mg/day (Myfortic) post-transplantation with dose adjustment as needed. Cyclosporine micro-emulsion will be initiated when renal function is established or no later than day 10 in a dose of 3mg/kg twice daily with adjustment to achieve a C2 target of 600-800 nanograms/ml. | Drug | 1 |
Primary outcome
Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test
Time frame: 6 months post transplant.
1 secondary outcome
Incidence of acute rejection
Time frame: 6 months post transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2008.
- Derived from this study: PubMed 23369458Cole EH, Prasad GV, Cardella CJ, Kim JS, Tinckam KJ, Cattran DC, Schiff JR, Landsberg DN, Zaltzman JS, Gill JS. A pilot study of reduced dose cyclosporine and corticosteroids to reduce new onset diabetes mellitus and acute rejection in kidney transplant recipients. Transplant Res. 2013 Jan 12;2(1):1. doi: 10.1186/2047-1440-2-1.
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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.
Edward Cole study director
University Health Network, Toronto
John Gill principal investigator
St. Paul's Hospital
Ramesh Prasad principal investigator
Unity Health Toronto
3 sites 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 Diabetes and Graft Rejection, run by University Health Network, Toronto at 3 sites in Canada.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward Cole (416-340-4800 ext. 4669, edward.cole@uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test (time frame: 6 months post transplant.). 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 NCT00706680, 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 27 Jun 2008.