End Stage Renal DiseasePhase 2NCT01502267
Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant
A Phase 2 study testing High dose IVIG and B cell depleting agents in people with End Stage Renal Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients. 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?
- High dose IVIG and B cell depleting agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Jan 2016
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- patients who are on the waiting list more than 4 years
- PRA I or II > 50%
Who cannot join
- Recent recipients of any live attenuated vaccine(s) within 4 weeks
- Subjects who have received IVIG or B cell depleting agents previously
- Subjects with positive result for viral hepatitis(B,C) or HIV infection
- Subjects with active infection
- Lactating or pregnant females
- Subjects who have history of malignancy in recent 5years
- Subjects who have experience of treatment for the psychiatric problem in recent 6months
- Subjects who have hematologic abnormality (Hb < 7g/dL, Platelet < 100,000/mm3, AST/ALT > 80IU)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Desensitization Protocol for Highly Sensitized Wait Listed Patients
The purpose of this study is to determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients.
Read the detailed description
HLA sensitization is known to be the most important barrier to deceased donor kidney allocation. Therefore, the investigators need to develop better strategies for managing pre-sensitized patients using desensitization protocol. In this study the investigators will used two kinds of medication for the reduction of circulating antibodies (high dose IVIg, B cell depleting agents) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplantation. After desensitization, the investigators will check that this treatment can increase their chances of receiving a kidney transplant.
- Conditions
- End Stage Renal Disease
- Being tested
- High dose IVIG and B cell depleting agents
- Keywords
- Waiting list, Deceased donor kidney transplantation, Desensitization, anti HLA antibody
- 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.
High dose IVIG and B cell depleting agentsDrug
Also called IVIG, Mabthera, Velcade
- IVIG(2g/kg two times on day 1, 30)
- Rituximab(375mg/m2 on day 3)
- Bortezomib(1.3mg/m2 four times on day 31, 34, 38, 41)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | This group will not receive IVIG and B cell depleting agents |
| Group 2 | Experimental | This group will receive IVIG and B cell depleting agents Receives: Drug: High dose IVIG and B cell depleting agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rates of kidney transplantation
Measured: from one to five years
Secondary outcomes (3)
Reduction in anti-HLA alloantibodies
Measured: 1year
Renal allograft survival
graft and patient survival
Measured: from one to five year
The number of serious complication
Measured: from one to five year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2014 (estimated)
- Study completionJan 2016 (estimated)
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 End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Curie Ahn, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502267
- Sponsor's protocol ID
- 11374
- Status last verified
- Jan 2012
- First submitted
- 24 Dec 2011
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jeong JC, Jambaldorj E, Kwon HY, Kim MG, Im HJ, Jeon HJ, In JW, Han M, Koo TY, Chung J, Song EY, Ahn C, Yang J. Desensitization Using Bortezomib and High-dose Immunoglobulin Increases Rate of Deceased Donor Kidney Transplantation. Medicine (Baltimore). 2016 Feb;95(5):e2635. doi: 10.1097/MD.0000000000002635.
PubMed 26844479
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Desensitization Protocol for Highly Sensitized Wait Listed Patients
- ClinicalTrials.gov ID
- NCT01502267
- Acronym / sponsor ID
- 11374
- Conditions
- End Stage Renal Disease
- Keywords
- Waiting list, Deceased donor kidney transplantation, Desensitization, anti HLA antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 30 Dec 2011 (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 determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients.
Detailed description
HLA sensitization is known to be the most important barrier to deceased donor kidney allocation. Therefore, the investigators need to develop better strategies for managing pre-sensitized patients using desensitization protocol. In this study the investigators will used two kinds of medication for the reduction of circulating antibodies (high dose IVIg, B cell depleting agents) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplantation. After desensitization, the investigators will check that this treatment can increase their chances of receiving a kidney transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –This group will not receive IVIG and B cell depleting agents |
| Group 2 | Experimental | Drug: High dose IVIG and B cell depleting agentsThis group will receive IVIG and B cell depleting agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- patients who are on the waiting list more than 4 years
- PRA I or II > 50%
Key exclusion criteria (8 listed)
- Recent recipients of any live attenuated vaccine(s) within 4 weeks
- Subjects who have received IVIG or B cell depleting agents previously
- Subjects with positive result for viral hepatitis(B,C) or HIV infection
- Subjects with active infection
- Lactating or pregnant females
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 |
|---|---|---|
| High dose IVIG and B cell depleting agentsAlso: IVIG, Mabthera, Velcade1. IVIG(2g/kg two times on day 1, 30) 2. Rituximab(375mg/m2 on day 3) 3. Bortezomib(1.3mg/m2 four times on day 31, 34, 38, 41) | Drug | Group 2 |
Primary outcome
The rates of kidney transplantation
Time frame: from one to five years
3 secondary outcomes
Reduction in anti-HLA alloantibodies
Time frame: 1year
Renal allograft survival
Time frame: from one to five year
The number of serious complication
Time frame: from one to five year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2012.
- Derived from this study: PubMed 26844479Jeong JC, Jambaldorj E, Kwon HY, Kim MG, Im HJ, Jeon HJ, In JW, Han M, Koo TY, Chung J, Song EY, Ahn C, Yang J. Desensitization Using Bortezomib and High-dose Immunoglobulin Increases Rate of Deceased Donor Kidney Transplantation. Medicine (Baltimore). 2016 Feb;95(5):e2635. doi: 10.1097/MD.0000000000002635.
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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.
Curie Ahn, MD principal investigator
Seoul National University Hospital
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 High dose IVIG and B cell depleting agents in people with End Stage Renal Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 3 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: status not confirmed, as of the sponsor's last update on 6 Jan 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 South Korea. 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?
Results are not available in the source record.
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?
The rates of kidney transplantation (time frame: from one to five 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 NCT01502267, 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 6 Jan 2012.