Kidney Graft Function Under the Immunosuppression Strategies

NCT01817322 | Completed Phase 4 DMC

• 1 other identifier: CERL080AKR09T
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Renal Disease

Keywords

kidney transplantation

Outcome Measures

Primary Outcomes (1)

• eGFR (abbreviated MDRD equation)

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

  6 months after transplantation

Secondary Outcomes (1)

• safety

  6 months after transplantation

Study Arms (2)

Myfortic® (Enteric-coated Mycophenolate Sodium)

EXPERIMENTAL

reduced cyclosporine+steroids+standard dose of myfortic

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

Myfortic

ACTIVE COMPARATOR

Conventional Dose+cyclosporine+steroid+Reduced Dose of Myfortic

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

Interventions

Standard Dose of Myfortic and Reduced Dose of Myfortic DRUG

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)

Also known as: Kidney Graft Function under the Immunosuppression Strategies

Myfortic; Myfortic® (Enteric-coated Mycophenolate Sodium)

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

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.

Also known as: Kidney Graft Function under the Immunosuppression Strategies

Myfortic; Myfortic® (Enteric-coated Mycophenolate Sodium)

Basiliximab injected both control group and experimental group DRUG

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.

Also known as: Kidney Graft Function under the Immunosuppression Strategies

Myfortic; Myfortic® (Enteric-coated Mycophenolate Sodium)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. multi-organ recipients, or dual kidney recipients or previous transplant recipients with any organs including the kidney ,bone marrow, or stem cells.
• \. 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.
• \. Patients with hypersensitivity to Mycophenolate sodium, Mycophenolate acid or Mycophenolate Mofetil or to any of the excipients.
• \. Patient with HGPRT(Hypoxanthin e-guanine phosphoribosyl-transferas) such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome.
• \. 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.
• \. 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.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Mycophenolic Acid; Prednisolone; Methylprednisolone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jong won HA, M.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Myoung-soo kim, M.D

  Yonsei University

  PRINCIPAL INVESTIGATOR

• chang-Kwon OH, M.D

  Ajou unversity medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgery M.D

Study Record Dates

• First Submitted: March 8, 2013
• First Posted: March 25, 2013
• Study Start: June 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 3, 2014

Record last verified: 2014-10