Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148252
Status:
TERMINATED
Last Update Posted:
2012-06-07
First Post:
2005-09-06
Brief Title:
Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant
Sponsor:
University of Oslo School of Pharmacy
Organization:
University of Oslo School of Pharmacy
Study Overview
Official Title:
Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant - Randomised Withdrawal of Mycophenolate Mofetil CellCept or Cyclosporine A Sandimmun Neoral
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
To high rejection rate in CsA withdrawal arm
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy
Detailed Description:
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy
Secondly to examine safety following withdrawal of CsA or MMF respectively by the following parameters
Biopsy verified acute rejection episodes time to first rejection and number of steroid resistant rejection episodes within 12 months
Hematology Hb WBC platelets abnormalities within 12 months
Graft and patient survival at 12 months and 5 years Absolute difference in renal function between withdrawal groups at 12 months Three monthly changes in renal function from drug withdrawal to 12 months Change in dyslipidemia frequency from drug withdrawal to 12 months Change in hypertension frequency from drug withdrawal to 12 months Change in glucose tolerance from drug withdrawal to 12 months Cumulative incidence of clinical infections resulting in hospitalization within 12 months
Sub protocols will also examine the following aspects
Cardiovascular Homocysteine Lipid peroxidation Microvascular function and vasoactive parameters Quality of life QoL ESRD SCL-TM SF-36 short version and EQ-5D GI-checklist extended questionnaires will be used
Pharmacoeconomical evaluation
Secondly to examine safety following withdrawal of CsA or MMF respectively by the following parameters
Biopsy verified acute rejection episodes time to first rejection and number of steroid resistant rejection episodes within 12 months
Hematology Hb WBC platelets abnormalities within 12 months
Graft and patient survival at 12 months and 5 years Absolute difference in renal function between withdrawal groups at 12 months Three monthly changes in renal function from drug withdrawal to 12 months Change in dyslipidemia frequency from drug withdrawal to 12 months Change in hypertension frequency from drug withdrawal to 12 months Change in glucose tolerance from drug withdrawal to 12 months Cumulative incidence of clinical infections resulting in hospitalization within 12 months
Sub protocols will also examine the following aspects
Cardiovascular Homocysteine Lipid peroxidation Microvascular function and vasoactive parameters Quality of life QoL ESRD SCL-TM SF-36 short version and EQ-5D GI-checklist extended questionnaires will be used
Pharmacoeconomical evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None