Disorder Related to Renal TransplantationPhase 1/2NCT00167661
Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation
A Phase 1/2 study testing Campath-1H in people with Disorder Related to Renal Transplantation, 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 and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Disorder Related to Renal Transplantation
- What is being tested?
- Campath-1H
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to May 2012
- Phase
- Phase 1/2
- 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 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must be a single-organ recipient (kidney only)
- Participants who are receiving their first living donor or deceased donor transplant
Who cannot join
- Participants who are recipients of HLA-identical living-donor renal transplants
- Participants with a PRA value > 10% within 30 days prior to the transplant
- Participants who have received a multi-organ transplant
- Participants who are who are positive for hepatitis C, hepatitis B surface antigen or HIV
- Participants who have received an investigational drug within 6 weeks of study entry
- Participants who have a previous history of, or who currently have, malignancies and/or lymphoma
Show all 9Show fewer
- Participants who have received corticosteroids within three months of transplantation
- Participants who are 3rd transplant recipients
- Female participants who are pregnant or lactating. Fertile female participants who are sexually active must agree to use an acceptable method of birth control during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.
- Being tested
- Campath-1H
- Keywords
- living or deceased donor renal transplant recipient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Campath-1HDrug
Also called Alemtuzumab
two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
| Study group | Role | What they receive |
|---|---|---|
| Campath 1-H | Experimental | Campath 1-H Receives: Drug: Campath-1H |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Graft Rejection
Measured: at 1, 3, 6, 12, and 24 months
Participant Graft Survival
Measured: at 6, 12, and 24 months
Secondary outcomes (8)
Estimated Glomerular Filtration Rate (EGFR)
Measure of renal function
Measured: at 1, 6, 12 and 24 months
Number of Participants With Infection
Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK)
Measured: up to 24 months
Number of Participants With Malignancy
Measured: up to 24 months
Growth Post-transplant Reported by Height Z Score
A z-score (aka, a standard score) indicates how many standard deviations an element is from the mean, in this case, height. A score of '0' is equal to the mean, a score less than 0 is less than the mean, and a score greater than 0 is greater than the mean.
Measured: up to 24 months
Number of Participants With Hypertension
Measured: up to 24 months
Number of Participants With Hyperlipidemia
Measured: up to 24 months
Participant Survival
Measured: at 6, 12, and 24 months
Number of Participant With Diabetes Mellitus
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionDec 2011
- Study completionMay 2012
Why it stopped: Enrollment suspended pending protocol revision to change study to observational
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 Disorder Related to Renal TransplantationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon M Bartosh, MD, Study chair, University of Wisconsin, MadisonSharon M Bartosh, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167661
- Sponsor's protocol ID
- 2011-0661
- Other IDs
- H-2003-0493, A536758, SMPH/PEDIATRICS/PEDIATRICS
- Status last verified
- Aug 2020
- First submitted
- 11 Sep 2005
- Last updated
- 21 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation
- ClinicalTrials.gov ID
- NCT00167661
- Acronym / sponsor ID
- 2011-0661
- Keywords
- living or deceased donor renal transplant recipient
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment suspended pending protocol revision to change study to observational
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 21 Sep 2020
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 and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Campath 1-H | Experimental | Drug: Campath-1HCampath 1-H |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Participants must be a single-organ recipient (kidney only)
- Participants who are receiving their first living donor or deceased donor transplant
Key exclusion criteria (9 listed)
- Participants who are recipients of HLA-identical living-donor renal transplants
- Participants with a PRA value > 10% within 30 days prior to the transplant
- Participants who have received a multi-organ transplant
- Participants who are who are positive for hepatitis C, hepatitis B surface antigen or HIV
- Participants who have received an investigational drug within 6 weeks of study entry
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-1HAlso: Alemtuzumabtwo intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant | Drug | Campath 1-H |
Primary outcome
Incidence of Graft Rejection
Time frame: at 1, 3, 6, 12, and 24 months
Participant Graft Survival
Time frame: at 6, 12, and 24 months
8 secondary outcomes
Estimated Glomerular Filtration Rate (EGFR)
Time frame: at 1, 6, 12 and 24 months
Number of Participants With Infection
Time frame: up to 24 months
Number of Participants With Malignancy
Time frame: up to 24 months
Growth Post-transplant Reported by Height Z Score
Time frame: up to 24 months
Number of Participants With Hypertension
Time frame: up to 24 months
Number of Participants With Hyperlipidemia
Time frame: up to 24 months
Participant Survival
Time frame: at 6, 12, and 24 months
Number of Participant With Diabetes Mellitus
Time frame: up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- 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.
Sharon M Bartosh, MD study chair
University of Wisconsin, Madison
Sharon M Bartosh, 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 Phase 1/2 study testing Campath-1H in people with Disorder Related to Renal Transplantation, 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 9 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: stopped early, as of the sponsor's last update on 21 Sep 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 21 Sep 2020). 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 Graft Rejection (time frame: at 1, 3, 6, 12, and 24 months). The study lists 2 primary outcomes in all. 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 21 Sep 2020.