Renal TransplantPhase 2NCT00365846
"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"
A Phase 2 study testing Campath-1H in people with Renal Transplant, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Campath-1H
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Jul 2006
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primary renal transplant (not HLA identical)
- ages 18-60 years
Who cannot join
- recipient panel reactive antibody level >10%
- recipient of a DCD kidney
- no prior organ transplant
- no multi-organ transplant recipient
- no subject who is currently receiving systemic corticosteroids
- no pregnant or lactating subjects
- no history of Hepatitis B, C or HIV positivity
- no recipient of a kidney with cold ischemia time >36 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation
The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.
Read the detailed description
Twenty nine primary recipients of either a live donor or deceased donor renal transplant were enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and maintenance sirolimus.
Subjects were followed for 3 years to compare the incidence and severity of rejection episodes, complications related to the immunosuppression, including infections, malignancies and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12 months (unless medically contraindicated).
- Conditions
- Renal Transplant
- Being tested
- Campath-1H
- Keywords
- prevent kidney rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Campath-1HDrug
| Study group | Role | What they receive |
|---|---|---|
| Campath 1H induction w/ Sirolimus immunosuppression | Experimental | Campath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus, Receives: Drug: Campath-1H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Allograft Rejection
Measured: 3 years
Secondary outcomes (5)
Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)
Measured: 3 years
Patient Survival
Measured: 3 years
Incidence of Post-transplant Infection
Event of post-transplant infection (more than one "event" might have been counted per participant)
Measured: 3 years
Incidence of Malignancies
Number of Participants Experiencing Malignancies
Measured: 3 years
Kidney Allograft Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startAug 2000
- Primary completionJul 2005
- Study completionJul 2006
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart J Knechtle, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365846
- Sponsor's protocol ID
- 2000-032
- Status last verified
- Sep 2012
- First submitted
- 16 Aug 2006
- Last updated
- 3 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Barth RN, Janus CA, Lillesand CA, Radke NA, Pirsch JD, Becker BN, Fernandez LA, Thomas Chin L, Becker YT, Odorico JS, D'Alessandro AM, Sollinger HW, Knechtle SJ. Outcomes at 3 years of a prospective pilot study of Campath-1H and sirolimus immunosuppression for renal transplantation. Transpl Int. 2006 Nov;19(11):885-92. doi: 10.1111/j.1432-2277.2006.00388.x.
PubMed 17018123Fehr T, Hubel K, de Rougemont O, Abela I, Gaspert A, Gungor T, Hauri M, Helmchen B, Linsenmeier C, Muller T, Nilsson J, Riesterer O, Scandling JD, Schanz U, Cippa PE. Successful Induction of Specific Immunological Tolerance by Combined Kidney and Hematopoietic Stem Cell Transplantation in HLA-Identical Siblings. Front Immunol. 2022 Jan 31;13:796456. doi: 10.3389/fimmu.2022.796456. eCollection 2022.
PubMed 35173720
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
- "A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation
- ClinicalTrials.gov ID
- NCT00365846
- Acronym / sponsor ID
- 2000-032
- Conditions
- Renal Transplant
- Keywords
- prevent kidney rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2000
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 18 Aug 2006 (estimated)
- Results
- Posted 30 Jul 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 the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.
Detailed description
Twenty nine primary recipients of either a live donor or deceased donor renal transplant were enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and maintenance sirolimus.
Subjects were followed for 3 years to compare the incidence and severity of rejection episodes, complications related to the immunosuppression, including infections, malignancies and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12 months (unless medically contraindicated).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Campath 1H induction w/ Sirolimus immunosuppression | Experimental | Drug: Campath-1HCampath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus, |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- primary renal transplant (not HLA identical)
- ages 18-60 years
Key exclusion criteria (8 listed)
- recipient panel reactive antibody level >10%
- recipient of a DCD kidney
- no prior organ transplant
- no multi-organ transplant recipient
- no subject who is currently receiving systemic corticosteroids
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 |
|---|---|---|
| Campath-1H | Drug | Campath 1H induction w/ Sirolimus immunosuppression |
Primary outcome
Incidence of Allograft Rejection
Time frame: 3 years
5 secondary outcomes
Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)
Time frame: 3 years
Patient Survival
Time frame: 3 years
Incidence of Post-transplant Infection
Time frame: 3 years
Incidence of Malignancies
Time frame: 3 years
Kidney Allograft Survival
Time frame: 3 years
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.
- Results publication: PubMed 17018123Barth RN, Janus CA, Lillesand CA, Radke NA, Pirsch JD, Becker BN, Fernandez LA, Thomas Chin L, Becker YT, Odorico JS, D'Alessandro AM, Sollinger HW, Knechtle SJ. Outcomes at 3 years of a prospective pilot study of Campath-1H and sirolimus immunosuppression for renal transplantation. Transpl Int. 2006 Nov;19(11):885-92. doi: 10.1111/j.1432-2277.2006.00388.x.
- Derived from this study: PubMed 35173720Fehr T, Hubel K, de Rougemont O, Abela I, Gaspert A, Gungor T, Hauri M, Helmchen B, Linsenmeier C, Muller T, Nilsson J, Riesterer O, Scandling JD, Schanz U, Cippa PE. Successful Induction of Specific Immunological Tolerance by Combined Kidney and Hematopoietic Stem Cell Transplantation in HLA-Identical Siblings. Front Immunol. 2022 Jan 31;13:796456. doi: 10.3389/fimmu.2022.796456. eCollection 2022.
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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 J Knechtle 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 Phase 2 study testing Campath-1H in people with 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 2 inclusion and 8 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 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?
Incidence of Allograft 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?
On the ClinicalTrials.gov record for NCT00365846, which also lists 2 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 3 Oct 2012.