Clinical trial NCT00537862: Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients
Official title: Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients ; A Prospective, Open Label, Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplant
Keywords: Kidney Transplant Patients
Immunosuppresion
Enteric-coated mycophenolate sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-10-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney transplant recipients


Eligibility criteria: Inclusion Criteria:

* Korean Males and females aged 18 to 65 years.
* Recipients of first, living unrelated or living related non-HLA identical donor kidney
* Transplant, treated with cyclosporine microemulsion (Cs-ME) as primary immunosuppressant.
* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication but at least for four months after randomization, even where there has been a history of infertility.

Exclusion Criteria:

* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
* Kidneys from cadaveric donors or HLA identical living related donors.
* Patients with any known hypersensitivity to enteric coated Mycophenolate sodium (EC-MPS) or other components of the formulation (e.g. lactose).
* Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \<1,500/mm3, and/or leukocytopenia (\<4,000/mm3 ), or hemoglobin \< 6g/dL .
* Patients who have received any investigational drug within 30 days prior to study entry.
* Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
* 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.
* Patients with clinically significant infection requiring continued therapy.
* Known positive HIV status.
* Positive HBsAg test, or Hepatitis C positive with advanced liver disease or with clinical or pathological diagnosis of cirrhosis.
* Evidence of drug and/or alcohol abuse

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Efficacy & safety of enteric-coated mycophenolate sodium combined with cyclosporine microemulsion & corticosteroids assessed by overall survival at 6 months, biopsy proven acute rejection, graft loss, adverse events and serious adverse events.
Secondary outcomes:
measure: Tolerability of full dose of EC-MPS assessed by dose reduction & treatment discontinuation rates due to adverse events
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Jeollanam-do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: