Primary Renal TransplantNCT00214201
Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
A study testing Calcineurin inhibitor withdrawal in people with Primary Renal Transplant, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Renal Transplant
- What is being tested?
- Calcineurin inhibitor withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to May 2009
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.
Who cannot join
- Recipients of HLA-identical living-donor renal transplants;
- PRA value >20% within 30 days of transplant;
- GFR <40ml/min;
- multi-organ transplant;
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.
- Conditions
- Primary Renal Transplant
- Being tested
- Calcineurin inhibitor withdrawal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcineurin inhibitor withdrawalDrug
stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Standard of Care CNI immunosuppression |
| 2 | Experimental | Calcineurin inhibitor withdrawal Receives: Drug: Calcineurin inhibitor withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Biopsy Proven Rejection
Measured: 3 years
Secondary outcomes (1)
Serum Creatinine at 36 Months (End of Study)
Measured: 36 months +/- 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionMay 2009
- Study completionMay 2009
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 Primary Renal TransplantStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Knechtle, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214201
- Sponsor's protocol ID
- 2003-125
- Status last verified
- Sep 2012
- First submitted
- 13 Sep 2005
- Last updated
- 3 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
- ClinicalTrials.gov ID
- NCT00214201
- Acronym / sponsor ID
- 2003-125
- Conditions
- Primary Renal Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 12 Sep 2012
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 determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Standard of Care CNI immunosuppression |
| 2 | Experimental | Drug: Calcineurin inhibitor withdrawalCalcineurin inhibitor withdrawal |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.
Key exclusion criteria (4 listed)
- Recipients of HLA-identical living-donor renal transplants;
- PRA value >20% within 30 days of transplant;
- GFR <40ml/min;
- multi-organ transplant;
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 |
|---|---|---|
| Calcineurin inhibitor withdrawalstopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy | Drug | 2 |
Primary outcome
Number of Participants With Biopsy Proven Rejection
Time frame: 3 years
1 secondary outcome
Serum Creatinine at 36 Months (End of Study)
Time frame: 36 months +/- 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2012.
- 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.
Stuart Knechtle, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcineurin inhibitor withdrawal in people with Primary Renal Transplant, run by University of Wisconsin, Madison 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 1 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 3 Oct 2012. 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?
Yes. Results are posted in the registry (first posted 12 Sep 2012). 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?
Number of Participants With Biopsy Proven Rejection (time frame: 3 years). 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 3 Oct 2012.