Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443508
Status:
UNKNOWN
Last Update Posted:
2007-03-06
First Post:
2007-03-04
Brief Title:
Reduction or Discontinuation of CNIs With Conversion to Everolimus-Based Immunosuppresion
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Reduction or Discontinuation of Calcineurine Inhibitors With Conversion to Everolimus-Based Immunosuppresion to Alleviate Chronic Allograft Nephropathy CAN in Kidney Transplant Recipients A Prospective Randomized Study
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose
The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance
The study will include two groups The study group of 30 patients and a matched control group with creatinine levels at similar range
The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance
The study will include two groups The study group of 30 patients and a matched control group with creatinine levels at similar range
Detailed Description:
This study is design to compare two different strategies aiming to lessen the degree of the ongoing process of allograft injury either by removing tacrolimus from the maintenance immunosuppressive protocol or by reducing tacrolimus dose
The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance
The study will include two groups The study group of 30 patients and a matched control group with creatinine levels at similar range
Patients will undergo the following baseline studies
1 Doppler ultrasound to exclude any mechanical or a vascular problem
2 A kidney biopsy to define the histological changes degree of interstitial fibrosis tubular and glomerular changes The biopsies will be stained also for C4D and for fibrinogenic markers TGF-beta and collagen
3 A 24-hour urine protein excretion and creatinine clearance
4 Echocardiography study
5 Carotid Ultrasound
The following parameters will be monitored every clinic visit throughout the study period
1 SMA-12 including creatinine levels
2 A complete blood count
3 Cholesterol HDL-cholesterol and triglyceride levels
4 Blood pressure measurements X2
5 The number of blood pressure medications
6 Cholesterol lowering medication requirement
7 Urine protein excretion quantitative spot-test
8 Protein amount in the urine
Study end points
The data will be evaluated based on an intention to treat analysis and the following parameters will be compared between the two groups
1 Creatinine levels and calculated creatinine clearance
2 Spot urine for Crprotein ratio
3 24-hr protein excretion
4 Change in peak diastolic and mean arterial blood pressure
5 The number and dosage of blood pressure medications
6 Cholesterol HDL and triglyceride levels
7 Proportion of patients on cholesterol lowering agents
8 Number and severity of biopsy proven acute rejection episodes
9 Incidence of biopsy proven chronic rejection depends on per protocol biopsy at end of study
10 Patient and graft survival
The primary goal is to assess the change in renal function at 6 and 12 months after conversion using creatinine levels and calculated creatinine clearance
The study will include two groups The study group of 30 patients and a matched control group with creatinine levels at similar range
Patients will undergo the following baseline studies
1 Doppler ultrasound to exclude any mechanical or a vascular problem
2 A kidney biopsy to define the histological changes degree of interstitial fibrosis tubular and glomerular changes The biopsies will be stained also for C4D and for fibrinogenic markers TGF-beta and collagen
3 A 24-hour urine protein excretion and creatinine clearance
4 Echocardiography study
5 Carotid Ultrasound
The following parameters will be monitored every clinic visit throughout the study period
1 SMA-12 including creatinine levels
2 A complete blood count
3 Cholesterol HDL-cholesterol and triglyceride levels
4 Blood pressure measurements X2
5 The number of blood pressure medications
6 Cholesterol lowering medication requirement
7 Urine protein excretion quantitative spot-test
8 Protein amount in the urine
Study end points
The data will be evaluated based on an intention to treat analysis and the following parameters will be compared between the two groups
1 Creatinine levels and calculated creatinine clearance
2 Spot urine for Crprotein ratio
3 24-hr protein excretion
4 Change in peak diastolic and mean arterial blood pressure
5 The number and dosage of blood pressure medications
6 Cholesterol HDL and triglyceride levels
7 Proportion of patients on cholesterol lowering agents
8 Number and severity of biopsy proven acute rejection episodes
9 Incidence of biopsy proven chronic rejection depends on per protocol biopsy at end of study
10 Patient and graft survival
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