Renal TransplantPhase 4NCT04033276
IVIG/Rituximab vs Rituximab in Kidney Transplant With de Novo Donor-specific Antibodies
A Phase 4 study testing Rituximab and intravenous immune globulin in people with Renal Transplant, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The objective of this study was to compare two strategies of de novo donor specific antibodies (DSA) and antibody-mediated rejection (AMR) prevention in renal transplant recipients: high dose intravenous immunoglobulin (IVIG)/rituximab regimens versus rituximab alone. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Rituximab and intravenous immune globulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 8 Jan 2019to 3 May 2022
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients have de novo production of DR or DQ DSA after renal transplantation Inclusion criteria requires all of the following
- age ≥ 19 years
- Renal transplants with eGFR ≥ 20 ml/min (by CKD-EPI equation) and change in the eGFR ≤ 20 within 3 months
- No history of biopsy proven acute T cell mediated rejection or antibody-mediated rejection within 3 months
- peak MFI of de novo DSA (DR or DQ) ≥ 1000
- A patient who agree to write a written consent form
Who cannot join
- age ≤ 18 years
- multi-organ transplantation
- Patients with no history of tacrolimus as immunosuppressants
- history of allergic or anaphylactic reaction to rituximab
- human immunodeficiency virus infection
- active infection
Show all 12Show fewer
- pregnancy or lactation
- history of drug abuse or alcohol abuse within 6 months
- history of malignancy within 5 years
- history of treatment for psychiatric problems
- hematologic or biochemical abnormalities (Hb < 7g/dL, Platelet < 1x105/mm3, AST/ALT > 80IU)
- A patient who do not want to participate in this study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
About this study
Official title: A Randomized, Open, Controlled Trial of High Dose IVIG/Rituximab Versus Rituximab in Kidney Transplant Patients With de Novo Donor-specific Antibodies
The objective of this study was to compare two strategies of de novo donor specific antibodies (DSA) and antibody-mediated rejection (AMR) prevention in renal transplant recipients: high dose intravenous immunoglobulin (IVIG)/rituximab regimens versus rituximab alone.
Read the detailed description
Although recent advances in immunosuppressive regimens after kidney transplantation (KT) have reduced the incidence and consequences of T-cell-mediated rejection (TCMR) and have improved short-term outcomes, long-term allograft loss attributable to AMR is still responsible for substantial medical and socioeconomic burdens in kidney transplant recipients. Numerous studies have shown that de novo DSA after KT are associated with AMR, which leads to allograft loss. IVIG is a medication that has emerged as a useful tool in modulating immunity, treatment of AMR and in desensitization protocol. Treatment with rituximab or combination of IVIG/rituximab has sought to further diminish antibody production (de novo DSA) in the treatment of AMR. Several studies have been reported, but in the absence of control groups or standardization of treatment, their efficacy is difficult to assess.
- Conditions
- Renal Transplant
- Being tested
- Rituximab, intravenous immune globulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called mabthera
IV rituximab
intravenous immune globulinDrug
Also called IVIG-SN
iv intravenous immune globulin
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Active comparator | Inj Rituximab 375mg/m2 IV given on day 0 Receives: Drug: Rituximab |
| Combination of high-dose IVIG and Rituximab | Active comparator | IV Rituximab 375mg/m2 on day 0 and IV high-dose IVIG 2g/kg on day 0 Receives: Drug: Rituximab; Drug: intravenous immune globulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in delta DSA MFI sum
change of pre- and post-treatment DSA MFI sum, monitoring DSA during follow-up period
Measured: baseline and 3 months post-treatment, 1 year post-treatment
Secondary outcomes (2)
Change in estimated glomerular filtration rate(eGFR) by CKD-EPI equation
change of pre- and post-treatment eGFR by CKD-EPI equation, monitoring eGFR during follow-up period
Measured: baseline and 3 months post-treatment, 1 year post-treatment
Development of antibody-mediated rejection (AMR)
To identify the development of AMR after treatment during follow-up period
Measured: up to 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start8 Jan 2019
- Primary completion31 Dec 2021
- Study completion3 May 2022
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 Renal TransplantStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, GC Biopharma Corp
- Responsible party
- Sponsor
- Investigators
- Jaeseok Yang, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033276
- Sponsor's protocol ID
- 20180138795
- Status last verified
- May 2022
- First submitted
- 24 Jul 2019
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim HW, Lee J, Heo SJ, Kim BS, Huh KH, Yang J. Comparison of high-dose IVIG and rituximab versus rituximab as a preemptive therapy for de novo donor-specific antibodies in kidney transplant patients. Sci Rep. 2023 May 11;13(1):7682. doi: 10.1038/s41598-023-34804-6.
PubMed 37169835
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Controlled Trial of High Dose IVIG/Rituximab Versus Rituximab in Kidney Transplant Patients With de Novo Donor-specific Antibodies
- ClinicalTrials.gov ID
- NCT04033276
- Acronym / sponsor ID
- 20180138795
- Conditions
- Renal Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Severance Hospital, GC Biopharma Corp
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 26 Jul 2019 (actual)
- 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 objective of this study was to compare two strategies of de novo donor specific antibodies (DSA) and antibody-mediated rejection (AMR) prevention in renal transplant recipients: high dose intravenous immunoglobulin (IVIG)/rituximab regimens versus rituximab alone.
Detailed description
Although recent advances in immunosuppressive regimens after kidney transplantation (KT) have reduced the incidence and consequences of T-cell-mediated rejection (TCMR) and have improved short-term outcomes, long-term allograft loss attributable to AMR is still responsible for substantial medical and socioeconomic burdens in kidney transplant recipients. Numerous studies have shown that de novo DSA after KT are associated with AMR, which leads to allograft loss. IVIG is a medication that has emerged as a useful tool in modulating immunity, treatment of AMR and in desensitization protocol. Treatment with rituximab or combination of IVIG/rituximab has sought to further diminish antibody production (de novo DSA) in the treatment of AMR. Several studies have been reported, but in the absence of control groups or standardization of treatment, their efficacy is difficult to assess.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Active comparator | Drug: RituximabInj Rituximab 375mg/m2 IV given on day 0 |
| Combination of high-dose IVIG and Rituximab | Active comparator | Drug: Rituximab, Drug: intravenous immune globulinIV Rituximab 375mg/m2 on day 0 and IV high-dose IVIG 2g/kg on day 0 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients have de novo production of DR or DQ DSA after renal transplantation Inclusion criteria requires all of the following
- age ≥ 19 years
- Renal transplants with eGFR ≥ 20 ml/min (by CKD-EPI equation) and change in the eGFR ≤ 20 within 3 months
- No history of biopsy proven acute T cell mediated rejection or antibody-mediated rejection within 3 months
- peak MFI of de novo DSA (DR or DQ) ≥ 1000
Key exclusion criteria (12 listed)
- age ≤ 18 years
- multi-organ transplantation
- Patients with no history of tacrolimus as immunosuppressants
- history of allergic or anaphylactic reaction to rituximab
- human immunodeficiency virus infection
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 |
|---|---|---|
| RituximabAlso: mabtheraIV rituximab | Drug | Combination of high-dose IVIG and Rituximab, Rituximab |
| intravenous immune globulinAlso: IVIG-SNiv intravenous immune globulin | Drug | Combination of high-dose IVIG and Rituximab |
Primary outcome
change in delta DSA MFI sum
Time frame: baseline and 3 months post-treatment, 1 year post-treatment
change of pre- and post-treatment DSA MFI sum, monitoring DSA during follow-up period
2 secondary outcomes
Change in estimated glomerular filtration rate(eGFR) by CKD-EPI equation
Time frame: baseline and 3 months post-treatment, 1 year post-treatment
Development of antibody-mediated rejection (AMR)
Time frame: up to 1 year post-treatment
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 26 Oct 2022.
- Derived from this study: PubMed 37169835Kim HW, Lee J, Heo SJ, Kim BS, Huh KH, Yang J. Comparison of high-dose IVIG and rituximab versus rituximab as a preemptive therapy for de novo donor-specific antibodies in kidney transplant patients. Sci Rep. 2023 May 11;13(1):7682. doi: 10.1038/s41598-023-34804-6.
- Individual participant dataSharing planned: No
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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.
Jaeseok Yang, M.D., Ph.D. principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rituximab and intravenous immune globulin in people with Renal Transplant, run by Seoul National University Hospital at 2 sites 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 6 inclusion and 12 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
change in delta DSA MFI sum (time frame: baseline and 3 months post-treatment, 1 year post-treatment). 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 NCT04033276, 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 26 Oct 2022.