Ignite Creation Date:
2024-05-05 @ 9:40 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00931255
Status:
TERMINATED
Last Update Posted:
2022-03-31
First Post:
2009-06-29
Brief Title:
Tacrolimus to Sirolimus Conversion for Delayed Graft Function
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Delayed Tacrolimus to Sirolimus Conversion in Renal Transplant Recipients With Delayed Graft Function
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The trial was stopped because of slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPA
Brief Summary:
The objective of this study is to evaluate the safety and efficacy of conversion from tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft function DGFand slow graft function SGF in improving graft function and delaying chronic allograft nephropathy The investigators hypothesize that conversion from tacrolimus to sirolimus in renal transplant recipients with DGFSGF in early months after surgery will improve graft function and decrease the progression of graft fibrosis
Detailed Description:
Eligible study subjects will be randomized into two groups 8-18 weeks after surgery One group will be maintained on tacrolimus according to the standard of care at our center In the second group tacrolimus will be converted to sirolimus with one week overlap between sirolimus therapy and tacrolimus taper All the deceased donor kidney transplant recipients transplanted at our center who experience DGFSGF are eligible for inclusion in this study if they meet the inclusionexclusion criteria as detailed later
Data will be collected on patient demographics duration on dialysis history of diabetes and chronic hepatitis C previous transplantation PRA donor source warm and cold ischemia time donor demographics and comorbidity such as diabetes and hypertension serum creatinine at the time of organ removal early graft function number of dialysis treatments after transplantation induction agent and immunosuppressive regimen including the dose or level of the drugs at 3 6 9 12 18 and 24 months Similar data regarding use of ACE inhibitorsARBs erythropoietic agents number of anti-hypertensives and lipid lowering agents will be collected In addition the following tests and procedures will be obtained for this study
1 GFR measurement by cold iothalamate method at one year after transplantation
2 Evaluation of routine surveillance graft biopsies for chronic changes at 3 and 12 months posttransplant by morphometric analysis
3 Spot urine protein albumin and creatinine measurement at 3 and 12 months
4 Estimate GFR at 3 and 12 months using MDRD CG and Nankivell formulas
5 Examine the surveillance and indicated biopsies for acute rejection and BK nephropathy
6 Fasting lipid profile at 3 and 12 months for all patients and 24 months for those with at least 2 years of follow up
7 Office blood pressure measurements at 3 and 12 months for all patients and 24 months for those with at least 2 years of follow up
8 Measurement of CRP IL-6 and MCP at 3 and 12 months
The safety measures will include
Incidence of leukopenia WBC 3000 or thrombocytopenia PLT 100000 hemoglobin level at 12 months proteinuria at 12 months incidence of oral aphthous ulcers incidence of new onset diabetes incidence of CMV infection and rate of drug withdrawal due to side effects
Data will be collected on patient demographics duration on dialysis history of diabetes and chronic hepatitis C previous transplantation PRA donor source warm and cold ischemia time donor demographics and comorbidity such as diabetes and hypertension serum creatinine at the time of organ removal early graft function number of dialysis treatments after transplantation induction agent and immunosuppressive regimen including the dose or level of the drugs at 3 6 9 12 18 and 24 months Similar data regarding use of ACE inhibitorsARBs erythropoietic agents number of anti-hypertensives and lipid lowering agents will be collected In addition the following tests and procedures will be obtained for this study
1 GFR measurement by cold iothalamate method at one year after transplantation
2 Evaluation of routine surveillance graft biopsies for chronic changes at 3 and 12 months posttransplant by morphometric analysis
3 Spot urine protein albumin and creatinine measurement at 3 and 12 months
4 Estimate GFR at 3 and 12 months using MDRD CG and Nankivell formulas
5 Examine the surveillance and indicated biopsies for acute rejection and BK nephropathy
6 Fasting lipid profile at 3 and 12 months for all patients and 24 months for those with at least 2 years of follow up
7 Office blood pressure measurements at 3 and 12 months for all patients and 24 months for those with at least 2 years of follow up
8 Measurement of CRP IL-6 and MCP at 3 and 12 months
The safety measures will include
Incidence of leukopenia WBC 3000 or thrombocytopenia PLT 100000 hemoglobin level at 12 months proteinuria at 12 months incidence of oral aphthous ulcers incidence of new onset diabetes incidence of CMV infection and rate of drug withdrawal due to side effects
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