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Kidney Graft Function Under the Immunosuppression Strategies (MyLowCsA)

Primary Purpose

Chronic Renal Disease

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Chronic Renal Disease focused on measuring kidney transplantation

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myfortic® (Enteric-coated Mycophenolate Sodium)

Myfortic

Arm Description

reduced cyclosporine+steroids+standard dose of myfortic

Conventional Dose+cyclosporine+steroid+Reduced Dose of Myfortic

Outcomes

Primary Outcome Measures

eGFR (abbreviated MDRD equation)

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

Secondary Outcome Measures

safety

graft survival and patient survival

Full Information

NCT ID

NCT01817322

First Posted

March 8, 2013

Last Updated

October 2, 2014

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01817322

Brief Title

Kidney Graft Function Under the Immunosuppression Strategies

Acronym

MyLowCsA

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 marrow suppression.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Disease

Keywords

kidney transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Myfortic® (Enteric-coated Mycophenolate Sodium)

Arm Type

Experimental

Arm Description

reduced cyclosporine+steroids+standard dose of myfortic

Arm Title

Myfortic

Arm Type

Active Comparator

Arm Description

Conventional Dose+cyclosporine+steroid+Reduced Dose of Myfortic

Intervention Type

Drug

Intervention Name(s)

Standard Dose of Myfortic and Reduced Dose of Myfortic

Other Intervention Name(s)

Kidney Graft Function under the Immunosuppression Strategies

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Kidney Graft Function under the Immunosuppression Strategies

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Basiliximab injected both control group and experimental group

Other Intervention Name(s)

Kidney Graft Function under the Immunosuppression Strategies

Intervention Description

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.

Primary Outcome Measure Information:

Title

eGFR (abbreviated MDRD equation)

Description

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

Time Frame

6 months after transplantation

Secondary Outcome Measure Information:

Title

safety

Description

graft survival and patient survival

Time Frame

6 months after transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jong won HA, M.D

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Myoung-soo kim, M.D

Organizational Affiliation

Yonsei University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

chang-Kwon OH, M.D

Organizational Affiliation

Ajou unversity medical center

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Kidney Graft Function Under the Immunosuppression Strategies

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