Kidney TransplantPhase 4NCT03794492
Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome
A Phase 4 study testing Mycophenolate mofetil 500mg Tab. or 250mg Cap., Tacrolimus and Methylprednisolone/prednisolone in people with Kidney Transplant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Mycophenolate mofetil 500mg Tab. or 250mg Cap., Tacrolimus and Methylprednisolone/prednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Mar 2018to 27 Apr 2023
- 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
- Over 19 years old(male or female)
- Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor
- Agreement with written informed consent
Who cannot join
- Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0
- Patients with high sensitization who need desensitization therapy
- Multi organ recipients or previous transplant with any organs
- Diagnosed with cancer within five years
- Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor
- Patients who have positive HIV, HBsAg or Anti-HCV test result
Show all 11Show fewer
- At screening
- Under treatment for active liver disease, or Over 3times upper than normal range of liver function test (T-bilirubin, AST, ALT)
- WBC<2,500/mm3, PLT <50,000/mm3, ANC<1,500/mm3
- Pregnant or lactating women
- In investigator's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM)
Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients
Read the detailed description
This study is a multi-center, non-comparative and phase IV clinical trial that evaluates incidence of Donor-Specific Antibody for 36 months after kidney transplantation when administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid
- Conditions
- Kidney Transplant
- Being tested
- Mycophenolate mofetil 500mg Tab. or 250mg Cap., Tacrolimus, Methylprednisolone/prednisolone, Basiliximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate mofetil 500mg Tab. or 250mg Cap.Drug
Also called Myrept® Cap./Tab.
- Orally, up to 1g BID(total 2g daily)
TacrolimusDrug
- Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml
Methylprednisolone/prednisoloneDrug
- Methyprednisolone 500mg / Prednisolone 5mg
BasiliximabDrug
- IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate mofetil | Experimental | One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap. Receives: Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.; Drug: Tacrolimus; Drug: Methylprednisolone/prednisolone; Drug: Basiliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSA(Donor-specific Anti-HLA Antibody)
Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation
Measured: 36 months
Secondary outcomes (1)
Incidence of composite efficacy failure
The frequency and percentage of composite efficacy failure (Treated-BPAMR \& ACR, graft loss, death and follow-up loss)
Measured: 12, 24, 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start31 Mar 2018
- Primary completion22 Jul 2022
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang-Kwan Oh, Ph.D, Study chair, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794492
- Sponsor's protocol ID
- 223KT17017
- Status last verified
- May 2023
- First submitted
- 3 Jan 2019
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM)
- ClinicalTrials.gov ID
- NCT03794492
- Acronym / sponsor ID
- 223KT17017
- Conditions
- Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 7 Jan 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.
Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients
Detailed description
This study is a multi-center, non-comparative and phase IV clinical trial that evaluates incidence of Donor-Specific Antibody for 36 months after kidney transplantation when administered with Tacrolimus, Mycophenolate mofetil, and corticosteroid
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate mofetil | Experimental | Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap., Drug: Tacrolimus, Drug: Methylprednisolone/prednisolone, Drug: BasiliximabOne arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 19 years old(male or female)
- Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor
- Agreement with written informed consent
Key exclusion criteria (11 listed)
- Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0
- Patients with high sensitization who need desensitization therapy
- Multi organ recipients or previous transplant with any organs
- Diagnosed with cancer within five years
- Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor
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 |
|---|---|---|
| Mycophenolate mofetil 500mg Tab. or 250mg Cap.Also: Myrept® Cap./Tab.- Orally, up to 1g BID(total 2g daily) | Drug | Mycophenolate mofetil |
| Tacrolimus- Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml | Drug | Mycophenolate mofetil |
| Methylprednisolone/prednisolone- Methyprednisolone 500mg / Prednisolone 5mg | Drug | Mycophenolate mofetil |
| Basiliximab- IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant) | Drug | Mycophenolate mofetil |
Primary outcome
DSA(Donor-specific Anti-HLA Antibody)
Time frame: 36 months
Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation
1 secondary outcome
Incidence of composite efficacy failure
Time frame: 12, 24, 36months
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 22 May 2024.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplant
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
Chang-Kwan Oh, Ph.D study chair
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mycophenolate mofetil 500mg Tab. or 250mg Cap., Tacrolimus and Methylprednisolone/prednisolone in people with Kidney Transplant, run by Chong Kun Dang Pharmaceutical 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 11 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 22 May 2024. 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 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?
DSA(Donor-specific Anti-HLA Antibody) (time frame: 36 months). 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 22 May 2024.