Kidney TransplantPhase 1/2NCT00642655
Rituximab and Intravenous Immunoglobulin (IVIG) for Desensitization in Renal Transplantation
A Phase 1/2 study testing IVIG and Rituximab in people with Kidney Transplant, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the safety and efficacy of IVIG in combination with Rituximab to lower the level of HLA-sensitive antibodies and block their ability to attack a transplanted organ in patients who are highly HLA-sensitized and are awaiting transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- IVIG and Rituximab
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to May 2007
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive Antibody [PRA]) of >30% and are eligible for transplantation at Cedars-Sinai Medical Center. We currently anticipate entering 20 patients over the course of the study. We currently have ~100 patients on our wait list that would meet the above criteria. Patients will be selected based on the ability of IVIG to inhibit the cytotoxic anti-HLA antibody activity in vitro. They will then receive IVIG 2gm/kg X1 on day 1 while on hemodialysis. Seven days later, the patients will receive Rituxan® 1gm in the CSMC Cancer Infusion Center as per protocol for Rituxan® infusion. The second Rituxan® infusion will be on day#22. The patients will have monitoring of anti-HLA antibody and outlined tests as shown above.
- Able and willing to give written informed consent and comply with the requirements of the study protocol
- Adequate liver function, as indicated by normal liver function tests (NL: AST, ALT, Bilirubin and negative tests for hepatitis C and hepatitis B.
- Negative serum pregnancy test (for women of child bearing age)
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
Who cannot join
- Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
- Receipt of a live vaccine within 4 weeks prior to randomization
- Previous Treatment with Rituximab (MabThera® / Rituxan®)
- Prior antibody therapy
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- History of HIV (positive HIV, HIV conducted during screening)
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- History of Hepatitis B and/or Hepatitis C
- History of recurrent significant infection or history of recurrent bacterial infections
- Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- Lack of peripheral venous access
- History of drug, alcohol, or chemical abuse within 6 months prior to screening
- Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or lactation
- Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of psychiatric disorder
- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Inability to comply with study and follow-up procedures
- Laboratory Exclusion Criteria (at Screening)
- Hemoglobin: < 8.5 gm/dL
- Platelets: < 100,000/mm
- AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.
- Positive Hepatitis B or C serology
- Positive HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Trial to Investigate the Safety and Efficacy of Rituximab and IVIG as Agents to Desensitize Highly-HLA Sensitized Dialysis Patients Awaiting Kidney Transplantation
The purpose of this study is to examine the safety and efficacy of IVIG in combination with Rituximab to lower the level of HLA-sensitive antibodies and block their ability to attack a transplanted organ in patients who are highly HLA-sensitized and are awaiting transplantation.
Read the detailed description
Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive Antibody {PRA}) of >30%. If patients meet these criteria, patients will be asked to have an assessment of the ability of IVIG to reduce the anti-HLA antibodies activity in the test tube. Patients will receive IVIG 2gm/kg x1 on hemodialysis. Seven days later, patients will receive Rituximab 1gm in the CSMC Infusion Center as per protocol for Rituximab infusion. The second Rituximab infusion will be on day #22. Additional IVIG infusion will be given at month one.
Patients will continue to be followed for an additional 12 months after the last IVIG infusion and will be asked to return for follow up visits at month 1 through 5, month 7 and 12.
- Conditions
- Kidney Transplant
- Being tested
- IVIG and Rituximab
- Keywords
- IVIG, Rituximab, Highly Sensitized, Kidney Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIG and RituximabDrug
IVIG 2gm/kg given intravenously on day#0 and day#30 Rituximab 1gm given intravenously on day#7 and day#22
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of transplantation
Measured: 12 months
Secondary outcomes (1)
Number and severity of rejection episodes
Measured: 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startSep 2005
- Primary completionMay 2007
- Study completionMay 2007
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 Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Biogen
- Investigators
- Stanley C. Jordan, MD, Principal investigator, Cedars-Sinai Medical CenterAshley A Vo, PharmD, Study director, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642655
- Sponsor's protocol ID
- U3176s
- Status last verified
- Mar 2008
- First submitted
- 19 Mar 2008
- Last updated
- 25 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Vo AA, Lukovsky M, Toyoda M, Wang J, Reinsmoen NL, Lai CH, Peng A, Villicana R, Jordan SC. Rituximab and intravenous immune globulin for desensitization during renal transplantation. N Engl J Med. 2008 Jul 17;359(3):242-51. doi: 10.1056/NEJMoa0707894.
PubMed 18635429
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial to Investigate the Safety and Efficacy of Rituximab and IVIG as Agents to Desensitize Highly-HLA Sensitized Dialysis Patients Awaiting Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00642655
- Acronym / sponsor ID
- U3176s
- Conditions
- Kidney Transplant
- Keywords
- IVIG, Rituximab, Highly Sensitized, Kidney Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc., Biogen
- Study start
- Sep 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 25 Mar 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.
The purpose of this study is to examine the safety and efficacy of IVIG in combination with Rituximab to lower the level of HLA-sensitive antibodies and block their ability to attack a transplanted organ in patients who are highly HLA-sensitized and are awaiting transplantation.
Detailed description
Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive Antibody {PRA}) of >30%. If patients meet these criteria, patients will be asked to have an assessment of the ability of IVIG to reduce the anti-HLA antibodies activity in the test tube. Patients will receive IVIG 2gm/kg x1 on hemodialysis. Seven days later, patients will receive Rituximab 1gm in the CSMC Infusion Center as per protocol for Rituximab infusion. The second Rituximab infusion will be on day #22. Additional IVIG infusion will be given at month one.
Patients will continue to be followed for an additional 12 months after the last IVIG infusion and will be asked to return for follow up visits at month 1 through 5, month 7 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients eligible for the study will be those who have anti-HLA antibody (Panel Reactive Antibody [PRA]) of >30% and are eligible for transplantation at Cedars-Sinai Medical Center. We currently anticipate entering 20 patients over the course of the study. We currently have ~100 patients on our wait list that would meet the above criteria. Patients will be selected based on the ability of IVIG to inhibit the cytotoxic anti-HLA antibody activity in vitro. They will then receive IVIG 2gm/kg X1 on day 1 while on hemodialysis. Seven days later, the patients will receive Rituxan® 1gm in the CSMC Cancer Infusion Center as per protocol for Rituxan® infusion. The second Rituxan® infusion will be on day#22. The patients will have monitoring of anti-HLA antibody and outlined tests as shown above.
- Able and willing to give written informed consent and comply with the requirements of the study protocol
- Adequate liver function, as indicated by normal liver function tests (NL: AST, ALT, Bilirubin and negative tests for hepatitis C and hepatitis B.
- Negative serum pregnancy test (for women of child bearing age)
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
Key exclusion criteria (23 listed)
- Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
- Laboratory Exclusion Criteria (at Screening)
- Hemoglobin: < 8.5 gm/dL
- Platelets: < 100,000/mm
- AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.
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 |
|---|---|---|
| IVIG and RituximabIVIG 2gm/kg given intravenously on day#0 and day#30 Rituximab 1gm given intravenously on day#7 and day#22 | Drug | – |
Primary outcome
Success of transplantation
Time frame: 12 months
1 secondary outcome
Number and severity of rejection episodes
Time frame: 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2008.
- Derived from this study: PubMed 18635429Vo AA, Lukovsky M, Toyoda M, Wang J, Reinsmoen NL, Lai CH, Peng A, Villicana R, Jordan SC. Rituximab and intravenous immune globulin for desensitization during renal transplantation. N Engl J Med. 2008 Jul 17;359(3):242-51. doi: 10.1056/NEJMoa0707894.
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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.
Stanley C. Jordan, MD principal investigator
Cedars-Sinai Medical Center
Ashley A Vo, PharmD study director
Cedars-Sinai Medical Center
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 IVIG and Rituximab in people with Kidney Transplant, run by Cedars-Sinai Medical Center 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 5 inclusion and 23 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 25 Mar 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success of transplantation (time frame: 12 months). 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 NCT00642655, 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 25 Mar 2008.