Kidney FailurePhase 4NCT02447822
Thymoglobulin Induction Therapy in Kidney Transplantation (6mg/kg vs 4mg/kg)
A Phase 4 study testing Thymoglobulin in people with Kidney Failure, run by Asan Medical Center.
Trial summary
This is a prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney transplantation. Patients are enrolled from June, 2015 for 24 months. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Failure
- What is being tested?
- Thymoglobulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to May 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with renal failure from 18 to 70 years of age
- Candidates for cadaveric or living donor kidney transplantation
- Patients who are able and willing to consent the protocol of the study
Who cannot join
- Patients who have been receiving immunosuppressive therapy before transplantation
- Patients who have received an investigational medication within the past 30 days
- Patients who have a known contraindication to the administration of antithymocyte globulin
- Patients who are suspected or known to have an infection or were seropositive for hepatitis B surface antigen (HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Patients who have had cancer (except non melanoma skin cancer) within the previous 2 years
- Pregnant women, nursing mothers, and women of childbearing potential who were not using condoms or oral contraceptives
About this study
Official title: A Prospective Randomized Controlled Study to Evaluate Feasibility and Safety of Early Steroid Withdrawal After 6mg/kg vs 4.5mg/kg Thymoglobulin Induction Therapy in Kidney Transplantation
This is a prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within one week after kidney transplantation for all the patients. Maintenance immunosuppressants are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of biopsy-proven acute rejection, delayed graft function, graft loss or death within one year post transplant.
- Conditions
- Kidney Failure
- Being tested
- Thymoglobulin
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymoglobulinDrug
6.0 mg/kg vs 4.5 mg/kg Thymoglobulin
| Study group | Role | What they receive |
|---|---|---|
| 6.0ATG | Active comparator | Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy Receives: Drug: Thymoglobulin |
| 4.5ATG | Active comparator | Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy Receives: Drug: Thymoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death
Measured: 12 months after kidney transplantation
Secondary outcomes (3)
Pathologic findings according to Banff 2013 criteria
Measured: 1 day at the time of biopsy
Overall rate of acute rejection
Measured: 12 months after kidney transplantation
The rate of steroid-free immunosuppressive regimen
Measured: 12 months after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (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 Kidney FailureStudies of the same condition, open and under way.
- More trials run by Asan 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duck Jong Han, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447822
- Sponsor's protocol ID
- AsanMC 2014-1213
- Status last verified
- May 2015
- First submitted
- 15 May 2015
- Last updated
- 19 May 2015
- Results posted
- No
Publications
Ko Y, Wee YM, Shin S, Kim MJ, Choi MY, Kim DH, Lim SJ, Jung JH, Kwon H, Kim YH, Han DJ. A prospective, randomized, non-blinded, non-inferiority pilot study to assess the effect of low-dose anti-thymocyte globulin with low-dose tacrolimus and early steroid withdrawal on clinical outcomes in non-sensitized living-donor kidney recipients. PLoS One. 2023 Mar 1;18(3):e0280924. doi: 10.1371/journal.pone.0280924. eCollection 2023.
PubMed 36857393
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study to Evaluate Feasibility and Safety of Early Steroid Withdrawal After 6mg/kg vs 4.5mg/kg Thymoglobulin Induction Therapy in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02447822
- Acronym / sponsor ID
- AsanMC 2014-1213
- Conditions
- Kidney Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 19 May 2015 (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 prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within one week after kidney transplantation for all the patients. Maintenance immunosuppressants are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of biopsy-proven acute rejection, delayed graft function, graft loss or death within one year post transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6.0ATG | Active comparator | Drug: ThymoglobulinRecipients who have 6.0 mg/kg Thymoglobulin as induction therapy |
| 4.5ATG | Active comparator | Drug: ThymoglobulinRecipients who have 4.5 mg/kg Thymoglobulin as induction therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients with renal failure from 18 to 70 years of age
- Candidates for cadaveric or living donor kidney transplantation
- Patients who are able and willing to consent the protocol of the study
Key exclusion criteria (6 listed)
- Patients who have been receiving immunosuppressive therapy before transplantation
- Patients who have received an investigational medication within the past 30 days
- Patients who have a known contraindication to the administration of antithymocyte globulin
- Patients who are suspected or known to have an infection or were seropositive for hepatitis B surface antigen (HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Patients who have had cancer (except non melanoma skin cancer) within the previous 2 years
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 |
|---|---|---|
| Thymoglobulin6.0 mg/kg vs 4.5 mg/kg Thymoglobulin | Drug | 4.5ATG, 6.0ATG |
Primary outcome
A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death
Time frame: 12 months after kidney transplantation
3 secondary outcomes
Pathologic findings according to Banff 2013 criteria
Time frame: 1 day at the time of biopsy
Overall rate of acute rejection
Time frame: 12 months after kidney transplantation
The rate of steroid-free immunosuppressive regimen
Time frame: 12 months after kidney transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
- Derived from this study: PubMed 36857393Ko Y, Wee YM, Shin S, Kim MJ, Choi MY, Kim DH, Lim SJ, Jung JH, Kwon H, Kim YH, Han DJ. A prospective, randomized, non-blinded, non-inferiority pilot study to assess the effect of low-dose anti-thymocyte globulin with low-dose tacrolimus and early steroid withdrawal on clinical outcomes in non-sensitized living-donor kidney recipients. PLoS One. 2023 Mar 1;18(3):e0280924. doi: 10.1371/journal.pone.0280924. eCollection 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Thymoglobulin in people with Kidney Failure, run by Asan Medical Center.
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 6 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 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death (time frame: 12 months after kidney transplantation). 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 NCT02447822, 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 19 May 2015.