End Stage Renal DiseaseNCT00167791
Rituximab Desensitization Therapy for Patients on the Waiting List for Kidney Transplant
A study testing rituximab in people with End Stage Renal Disease, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This is a study of patients who have a high risk of kidney rejection before kidney transplant. The hypothesis is that treatment with a medication called rituximab will make it possible for them to receive a kidney transplant from a donor who previously did not present a good match. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- rituximab
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Mar 2008
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active status on a kidney transplant waiting list with positive cross match against a living donor
Who cannot join
- Receipt of a live vaccine within 4 weeks prior to randomization
- Previous Treatment with Rituximab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Trial Using Multi-dose Rituximab as Induction and Desensitization Therapy for Patients on the Waiting List for Kidney Transplant With a Positive Donor Specific Crossmatch to a Living Donor
This is a study of patients who have a high risk of kidney rejection before kidney transplant. The hypothesis is that treatment with a medication called rituximab will make it possible for them to receive a kidney transplant from a donor who previously did not present a good match.
- Conditions
- End Stage Renal Disease
- Being tested
- rituximab
- Keywords
- transplant, desensitization, kidney transplant
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Rituximab 375mg/m2 IV weekly times 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful transplantation.
Measured: assess 4 weeks after Rituximab treatment completed
Transplant success or failure following the desensitization protocol.
Measured: ongoing assessment for 2 years after transplant
Secondary outcomes (1)
Decrease in incidence of humoral rejection to less than 50% at 1 year.
Measured: assess 1 year after transplant
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 startJul 2005
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Yolanda T Becker, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167791
- Sponsor's protocol ID
- H-2004-0265
- Other IDs
- RIST
- Status last verified
- Apr 2014
- First submitted
- 9 Sep 2005
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial Using Multi-dose Rituximab as Induction and Desensitization Therapy for Patients on the Waiting List for Kidney Transplant With a Positive Donor Specific Crossmatch to a Living Donor
- ClinicalTrials.gov ID
- NCT00167791
- Acronym / sponsor ID
- H-2004-0265
- Conditions
- End Stage Renal Disease
- Keywords
- transplant, desensitization, kidney transplant
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 14 Sep 2005 (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 is a study of patients who have a high risk of kidney rejection before kidney transplant. The hypothesis is that treatment with a medication called rituximab will make it possible for them to receive a kidney transplant from a donor who previously did not present a good match.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active status on a kidney transplant waiting list with positive cross match against a living donor
Key exclusion criteria (2 listed)
- Receipt of a live vaccine within 4 weeks prior to randomization
- Previous Treatment with Rituximab
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 |
|---|---|---|
| rituximabRituximab 375mg/m2 IV weekly times 4 weeks | Drug | – |
Primary outcome
Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful transplantation.
Time frame: assess 4 weeks after Rituximab treatment completed
Transplant success or failure following the desensitization protocol.
Time frame: ongoing assessment for 2 years after transplant
1 secondary outcome
Decrease in incidence of humoral rejection to less than 50% at 1 year.
Time frame: assess 1 year after transplant
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
Yolanda T Becker, MD study chair
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 rituximab in people with End Stage Renal Disease, 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 2 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: withdrawn, as of the sponsor's last update on 14 Oct 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful transplantation. (time frame: assess 4 weeks after Rituximab treatment completed). 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 14 Oct 2015.