Clinical Trials Logo
  1. Home
  2. Renal Transplantation
  3. NCT00239070
  4. Details
NCT00239070 Clinical Trial

Extension Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

Renal Transplantation Clinical Trial

Official title:
A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00239070
Other study ID # CERL080A2405IN01E1
Secondary ID
Status Completed
Phase Phase 3
First received October 12, 2005
Last updated January 28, 2011
Start date April 2003
Est. completion date May 2006

Study information
Verified date January 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial Summary

This extension study is to assess the long-term safety of EC-MPS

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion / Exclusion Criteria - All patients who completed study CERL080A2405-IN01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Other protocol-defined inclusion / exclusion criteria may apply

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Enteric-Coated Mycophenolate Sodium (EC-MPS)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Outcome
Type Measure Description Time frame Safety issue
Primary To assess patient and graft survival, acute rejection incidence, graft function and specific pertinent safety parameters in de novo renal transplant recipients.
Secondary To assess the respective influence of parameters (demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications) on clinical outcomes.
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06026592 - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Active, not recruiting NCT02444429 - 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation Phase 3
Completed NCT02238418 - Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria. Phase 4
Completed NCT01729494 - Belatacept Early Steroid Withdrawal Trial Phase 4
Terminated NCT01436305 - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation Phase 2
Completed NCT02843295 - Catalytic Antibodies to Predict Uninvasively Late Transplant Failure N/A
Terminated NCT01276834 - Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation Phase 4
Completed NCT00842699 - Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab N/A
Completed NCT00525681 - Interaction Between Rimonabant and Cyclosporine and Tacrolimus Phase 4
Completed NCT00189735 - A Study to Evaluate FK778 in Kidney Transplant Patients Phase 2
Completed NCT00776750 - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients Phase 4
Recruiting NCT04052867 - Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy N/A
Recruiting NCT03114826 - Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients N/A
Completed NCT02587052 - A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
Completed NCT02020642 - Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx) N/A
Completed NCT01435291 - AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation Phase 4
Recruiting NCT01001065 - Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis N/A
Completed NCT00978965 - Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs
Recruiting NCT00903188 - Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation Phase 4
Completed NCT00419575 - Renal Transplantation With Immune Monitoring N/A