Kidney TransplantationPhase 4OPTIMUMNCT01159080
Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients
A Phase 4 study testing routine dose tacrolimus and less myfortic and reduced dose tacrolimus and conventional myfortic in people with Kidney Transplantation, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects Primary endpoints: 1. estimated GFR (MDRD equation) 12 months after randomization 2. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- routine dose tacrolimus and less myfortic and reduced dose tacrolimus and conventional myfortic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2010to 30 Nov 2016
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
<Inclusion criteria>
- The patients between the ages of 20 and 75 years who received kidney transplantation one to five years prior to the study.
- Taking tacrolimus and corticosteroid, with or without additional purine synthesis inhibitor within the recent 3 months
- Patients with serum creatinine (sCr) level ≤ 2.0 mg/dL and variation of sCr < 30% for recent 3 months
- Patients with urine proteinuria/creatinine ratio (PCR) ≤ 1 g/g, or 24 hour urine protein ≤ 1g/day for recent 3 months
- Patients who provided informed consent.
<Exclusion criteria>
- Patients who received combined non-renal transplantation, multiple kidney transplantation or re-transplantation
- Patients whose graft from non-heart beating cadaveric donor
- graft from HLA-identical living related donor
- ABO blood group incompatible donor or HLA desensitized recipients
- Patients with hypersensitivity history to mycophenolate sodium, mycophenolate acid, or mycophenolate mofetil, or to any other excipients
- Patients with hypoxanthin e-guanine phosphoribosyl-transferase such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome
- Patients with history of disease which could affect absorption of study medication (e.g. diabetic gastropathy, previous gastrectomy)
- Patients with positive serologic test results, in recipient or donor, for human immunodeficiency virus, hepatitis B or C virus
- Patients with liver function test abnormality (alanine aminotransferase, aspartate aminotransferase, or total bilirubin > 3 times from upper normal limit), neutropenia (absolute neutrophil count < 1,500/uL or white blood cell count < 2,500/uL), or thrombocytopenia (platelet < 75,000)
- Patients with history of cancer within 5 years, except for successfully treated localized non-melanocytic skin cancer
- Patients who were either pregnant, lactating, planning to become pregnant in the next 12 months
- Patients who taken medicine from other trial within 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Organ Function Preservation by the Combination Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients: OPTIMUM Study
To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects
Primary endpoints:
- estimated GFR (MDRD equation) 12 months after randomization
- estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)
- Conditions
- Kidney Transplantation
- Being tested
- routine dose tacrolimus and less myfortic, reduced dose tacrolimus and conventional myfortic
- Keywords
- immunosuppression control in kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine dose tacrolimus and less myforticDrug
oral regular dose of tacrolimus + less dose of myfortic trough level of tacrolimus will be 5-10 ng/mL and oral myfortic dose will be 180-360 mg twice a day
reduced dose tacrolimus and conventional myforticDrug
low dose of tacrolimus + maximum dose of myfortic target trough level of tacrolimus should be reduced to 2-5 ng/mL for 3 months after randomization and oral MPS dose increased to 540-720mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| routine dose tacrolimus and less myfortic | Active comparator | Not described Receives: Drug: routine dose tacrolimus and less myfortic |
| reduced dose tacrolimus and conventional myfortic | Experimental | Not described Receives: Drug: reduced dose tacrolimus and conventional myfortic |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimated GFR (MDRD equation)12 months after randomization
Measured: 12 months after randomization
Secondary outcomes (6)
Urine protein excretion
24hr urine collection or urine protein/creatinine ratio
Measured: 12 months after randomization
graft survival
12 month graft survival
Measured: 12 month after randomization
follow-up loss
frequency of follow-up loss
Measured: From randomization to 12 months after randomization
Allograft biopsy
number of performed allograft biopsy performed
Measured: From randomization to 12 months after randomization
Treated or biopsy proven acute rejection
Measured: From randomization to 12 months after randomization
estimated GFR change from randomization to end of the study
calculated by MDRD equation and Nankivell equation
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study start1 Apr 2010
- Primary completion30 Oct 2016
- Study completion30 Nov 2016
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 TransplantationStudies 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Samsung Medical Center
- Responsible party
- Principal investigator, Su-Kil Park, Asan Medical Center
- Investigators
- Su-Kil Park, MD,PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159080
- Sponsor's protocol ID
- CERL080AKR07T
- Other IDs
- CERL080AKR07T
- Acronym
- OPTIMUM
- Status last verified
- Mar 2017
- First submitted
- 6 Jul 2010
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Park S, Kim YS, Lee J, Huh W, Yang CW, Kim YL, Kim YH, Kim JK, Oh CK, Park SK. Reduced Tacrolimus Trough Level Is Reflected by Estimated Glomerular Filtration Rate (eGFR) Changes in Stable Renal Transplantation Recipients: Results of the OPTIMUM Phase 3 Randomized Controlled Study. Ann Transplant. 2018 Jun 12;23:401-411. doi: 10.12659/AOT.909036.
PubMed 29891834
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organ Function Preservation by the Combination Treatment of the optImuM Dose of calcineUrin Inhibitor and Mycophenolate Sodium in Kidney Recipients: OPTIMUM Study
- ClinicalTrials.gov ID
- NCT01159080
- Acronym / sponsor ID
- OPTIMUM / CERL080AKR07T
- Conditions
- Kidney Transplantation
- Keywords
- immunosuppression control in kidney transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Samsung Medical Center
- Study start
- 1 Apr 2010 (actual)
- Primary completion
- 30 Oct 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 9 Jul 2010 (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.
To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects
Primary endpoints:
- estimated GFR (MDRD equation) 12 months after randomization
- estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine dose tacrolimus and less myfortic | Active comparator | Drug: routine dose tacrolimus and less myfortic |
| reduced dose tacrolimus and conventional myfortic | Experimental | Drug: reduced dose tacrolimus and conventional myfortic |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| routine dose tacrolimus and less myforticoral regular dose of tacrolimus + less dose of myfortic trough level of tacrolimus will be 5-10 ng/mL and oral myfortic dose will be 180-360 mg twice a day | Drug | routine dose tacrolimus and less myfortic |
| reduced dose tacrolimus and conventional myforticlow dose of tacrolimus + maximum dose of myfortic target trough level of tacrolimus should be reduced to 2-5 ng/mL for 3 months after randomization and oral MPS dose increased to 540-720mg twice a day | Drug | reduced dose tacrolimus and conventional myfortic |
Primary outcome
estimated GFR (MDRD equation)12 months after randomization
Time frame: 12 months after randomization
6 secondary outcomes
Urine protein excretion
Time frame: 12 months after randomization
graft survival
Time frame: 12 month after randomization
follow-up loss
Time frame: From randomization to 12 months after randomization
Allograft biopsy
Time frame: From randomization to 12 months after randomization
Treated or biopsy proven acute rejection
Time frame: From randomization to 12 months after randomization
estimated GFR change from randomization to end of the study
Time frame: 12 months after randomization
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 14 Mar 2017.
- Derived from this study: PubMed 29891834Park S, Kim YS, Lee J, Huh W, Yang CW, Kim YL, Kim YH, Kim JK, Oh CK, Park SK. Reduced Tacrolimus Trough Level Is Reflected by Estimated Glomerular Filtration Rate (eGFR) Changes in Stable Renal Transplantation Recipients: Results of the OPTIMUM Phase 3 Randomized Controlled Study. Ann Transplant. 2018 Jun 12;23:401-411. doi: 10.12659/AOT.909036.
Related trials for Kidney Transplantation
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.
Su-Kil Park, MD,PhD principal investigator
Asan 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 4 study testing routine dose tacrolimus and less myfortic and reduced dose tacrolimus and conventional myfortic in people with Kidney Transplantation, run by Asan Medical Center 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?
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 14 Mar 2017. 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?
estimated GFR (MDRD equation)12 months after randomization (time frame: 12 months after randomization). 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 NCT01159080, 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 14 Mar 2017.