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Chronic Renal DiseasePhase 4MyLowCsANCT01817322

Kidney Graft Function Under the Immunosuppression Strategies

A Phase 4 study testing Standard Dose of Myfortic and Reduced Dose of Myfortic in people with Chronic Renal Disease, run by Samsung Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To demonstrate that cyclosporine-sparing immunosuppressions with the standard dose of Enteric-Coated Mycophenolate Sodium would preserve renal graft function after transplantation without an increase of incidences of adverse events, such as biopsy confirmed acute rejection, local or systemic infections, and bone… Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Renal Disease
What is being tested?
Standard Dose of Myfortic and Reduced Dose of Myfortic
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
Jun 2011to Aug 2013
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female patients with end-stage renal disease aged 20 to 65 years undergoing primary kidney transplantation
  • Kidney recipients who should be transplanted a kidney from a decease or living donor aged between 15 and 65 years
  • Patients who have given written informed consent to participate in the study

Who cannot join

  • 1. multi-organ recipients, or dual kidney recipients or previous transplant recipients with any organs including the kidney ,bone marrow, or stem cells.
  • 2. Recipients who should be transplanted the kidney from a non-heart beating donor, an ABO incompatible donor ,or a lymphocyte cross-match positive donor 3. Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
  • 4. Patients with hypersensitivity to Mycophenolate sodium, Mycophenolate acid or Mycophenolate Mofetil or to any of the excipients.
  • 5. Patient with HGPRT(Hypoxanthin e-guanine phosphoribosyl-transferas) such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome.
  • 6. Patients who have tested positive for HIV, HCV and HBV surface antigen. 7. Recipients of organs from donors who tested positive for HBsAg, HCV, HIV 8. Patients with any known hypersensitivity to cyclosporine or other components of the formulations 9. Patients who are applicable to the contradiction of Sandimune Neoral 10. Patients who have received any investigational drug within 30 days prior to study entry.
  • 11. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
  • 12. Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication, and/or presence of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.
  • 13. Evidence of drug, alcohol abuse, and/or other psychiatric illness within the last 6 months prior to study enroll 14. At the time of the screen evaluation for this study, patients with platelet count<50,000/mm3, absolute neutrophil count of <1,500/mm3, white blood cell count of < 4,500/mm3, or patients who have an abnormal liver profile such as ALT, AST Alk Phos or total bilirubin>3 times the upper normal limit.

About this study

Official title: Kidney Graft Function Under the Immunosuppression Strategies With Low Dose of Neoral®(Cyclosporine) and Standard Dose of Myfortic®(Enteric-Coated Mycophenolate Sodium) vs. With Conventional Dose of Neoral®(Cyclosporine) and Reduced Dose of Myfortic®(Enteric-Coated Mycophenolate Sodium) in De Novo Renal Transplant Recipients

To demonstrate that cyclosporine-sparing immunosuppressions with the standard dose of Enteric-Coated Mycophenolate Sodium would preserve renal graft function after transplantation without an increase of incidences of adverse events, such as biopsy confirmed acute rejection, local or systemic infections, and bone marrow suppression.

Read the detailed description

This clinical investigation will be the open-label, prospective, multi-center, 1:1 randomized comparative, longitudinal, and investigator-initiated study. Patients with end-stage renal disease will be assessed for the eligibility, and then be randomized using random number table into one of two groups prior to kidney transplantation.

Immunosuppression consisted of Cyclosporine(Neoral®), Methylprednisolone OR prednisone OR deflazacort(Brand name is not designated) and Enteric-Coated Mycophenolate Sodium(Myfortic®). Basilixumab(Simulect®) will be given just prior to transplant and 4 days after transplantation. The Enteric-Coated Mycophenolate Sodium will be given orally at the dose of 720 mg BID for Group A (investigational) or 360 mg BID for Group B (comparator), starting at two days after transplantation, as shown in the figure below. Cyclosporine will be given orally at a dose of 10 mg/Kg/day starting at a day before transplantation. Within a month after transplantation, the dose of the drug will be individually adjusted with goal trough blood level between 100 ng/mL and 200 ng/mL for Group A or between 200 ng/mL and 300 ng/mL for Group B, as displayed in the table below. From a month to 2 months post-transplantation, the target blood trough levels of cyclosporine will be reduced to between 75 ng/mL and 150 ng/mL for Group A or between 150 ng/mL and 250 ng/mL for Group B. From 2 months to 4 months post-transplantation, it will be further reduced to between 50 ng/mL and 125 ng/mL for Group A or between 125 ng/mL and 200 ng/mL for Group B. After 4 months post-transplantation, it will be further reduced to between 50 ng/mL and 100 ng/mL for Group A or between 100 ng/mL and 200 ng/mL for Group B.

Being tested
Standard Dose of Myfortic and Reduced Dose of Myfortic, Prednisolone OR methylprednisolone OR deflazacort injected both control group and experimental group, Basiliximab injected both control group and experimental group
Keywords
kidney transplantation
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Dose of Myfortic and Reduced Dose of MyforticDrug

    Also called Kidney Graft Function under the Immunosuppression Strategies

    Low Dose of Neoral (Cyclosporine) and Standard Dose of Myfortic (Enteric-Coated Mycophenolate Sodium) vs. with Conventional Dose of Neoral (Cyclosporine) and Reduced Dose of Myfortic (Enteric-Coated Mycophenolate Sodium)

  • Prednisolone OR methylprednisolone OR deflazacort injected both control group and experimental groupDrug

    Also called Kidney Graft Function under the Immunosuppression Strategies

    500 mg IV Injection in OP Day and 250 mg IV injection in POD1(1 Post op day). And then the drug dose is gradually reduced following the study institution's protocol. But the subject must be take the dose of 5mg of the drug per one day. The drug dose should be controlled on the basis of 5mg of Prednisolone. It can be used with the same dose of methylprednisolone 4 mg or deflazacort 6 mg.

  • Basiliximab injected both control group and experimental groupDrug

    Also called Kidney Graft Function under the Immunosuppression Strategies

    The subject must be injected 20 mg of Simulect in Kidney transplantation day and just before the OP. After 4 days(96hour ± 12hr), the subject must be injected 20mg of Simulect, again.

Study groups in NCT01817322
Study groupRoleWhat they receive
Myfortic® (Enteric-coated Mycophenolate Sodium)Experimentalreduced cyclosporine+steroids+standard dose of myfortic
Receives: Drug: Standard Dose of Myfortic and Reduced Dose of Myfortic; Drug: Prednisolone OR methylprednisolone OR deflazacort injected both control group and experimental group; Drug: Basiliximab injected both control group and experimental group
MyforticActive comparatorConventional Dose+cyclosporine+steroid+Reduced Dose of Myfortic
Receives: Drug: Standard Dose of Myfortic and Reduced Dose of Myfortic; Drug: Prednisolone OR methylprednisolone OR deflazacort injected both control group and experimental group; Drug: Basiliximab injected both control group and experimental group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. eGFR (abbreviated MDRD equation)

    Primary objective: To compare the renal function with eGFR (abbreviated MDRD equation) 6 months after transplantation

    Measured: 6 months after transplantation

Secondary outcomes (1)

  1. safety

    graft survival and patient survival

    Measured: 6 months after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2013 (estimated)
  2. Study startJun 2011
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

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
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01817322
Sponsor's protocol ID
CERL080AKR09T
Acronym
MyLowCsA
Status last verified
Oct 2014
First submitted
8 Mar 2013
Last updated
3 Oct 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Standard Dose of Myfortic and Reduced Dose of Myfortic in people with Chronic Renal Disease, run by Samsung 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 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: finished, as of the sponsor's last update on 3 Oct 2014. 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?

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?

eGFR (abbreviated MDRD equation) (time frame: 6 months after 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 NCT01817322.

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 3 Oct 2014.

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