Status:
COMPLETED
Kidney Graft Function Under the Immunosuppression Strategies
Lead Sponsor:
Samsung Medical Center
Conditions:
Chronic Renal Disease
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01817322
Start Date
June 1 2011
End Date
August 1 2013
Last Update
October 3 2014
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