Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446576
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2007-03-12
Brief Title:
The Effect of Epoetin Alfa on Cardiac Function and Quality of Life in Patients With Early Renal Kidney Disease
Sponsor:
Janssen-Cilag BV
Organization:
Janssen-Cilag BV
Study Overview
Official Title:
A Study in Early Renal Insufficiency Patients to Assess the Effect of Maintaining Three Different Hemoglobin Levels With the Use of Erythropoetin Alpha on Left Ventricular Hypertrophy and Dilation and Quality if Life The Cardiac Results of Early Treatment of Anaemia CRETA Study
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
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:
The purpose of this study is to assess whether maintaining hemoglobin Hb levels at normal or sub-normal levels with Epoetin Alfa can influence the health status left ventricular mass and quality of life of early renal insufficiency subjects without additional safety concerns
Detailed Description:
The use of Epoetin alfa in the treatment of anaemia in chronic renal failure CRF patients is well accepted The severity of anaemia in CRF patients increases with the degree of renal dysfunction Thus the most severe degree of anaemia is generally found in patients with end stage renal disease who must be maintained on dialysis Nevertheless a significant number of early renal insufficiency patients are also seen to be anaemic
Most patients in Europe with end stage renal disease are maintained at an Hb level between 6 and 8 mmoll According to a survey during the second European Epoetin symposium Creta 1998 only 20 is maintained at Hb 8 mmoll but most are maintained at values lower than 8 mmoll Even about 40 was maintained at Hb 6 mmoll
A number of studies have found a relationship between left ventricular hypertrophy and haemoglobin in dialysis and pre-dialysis patients Also a relation between LVH and morbidity and mortality has been found For this reason it should be a suggestion to treat anaemia towards a higher level
To treat Hb to a higher level a choice can be made to correct Hb when it has dropped to a very low level after renal disease has reached an advanced stage or alternatively to prevent anaemia in an early stage of renal disease In an analysis of the normal hematocrit trial Macdougall and Ritz suggest the latter This is the main purpose of this trial
Treatment with Epoetin alfa also makes patients feel better physically when their exercise capacity improves During treatment with Epoetin alfa several secondary effects may simultaneously influence the maximal exercise capacity after correction of the anaemia The improved well-being may result in an increase in physical activity and exercise capacity can be further improved by such conditioning The improved oxygen transport after correction of anaemia reverses the circulatory adaptation to hypoxia and most studies have shown a decrease in cardiac output at rest and an increase in peripheral resistance However approximately one-third of chronic renal failure patients treated with Epoetin alfa have episodes of hypertension and may require increased doses of anti-hypertensive medication
This prospective study will assess whether maintaining Hb levels at normal or sub-normal levels can influence the health status left ventricular mass and quality of life QoL of early renal insufficiency subjects without additional safety concerns The patients will receive Epoetin Alfa as subcutaneous or intravenous injections in variable dosages for a maximum of 42 months
Most patients in Europe with end stage renal disease are maintained at an Hb level between 6 and 8 mmoll According to a survey during the second European Epoetin symposium Creta 1998 only 20 is maintained at Hb 8 mmoll but most are maintained at values lower than 8 mmoll Even about 40 was maintained at Hb 6 mmoll
A number of studies have found a relationship between left ventricular hypertrophy and haemoglobin in dialysis and pre-dialysis patients Also a relation between LVH and morbidity and mortality has been found For this reason it should be a suggestion to treat anaemia towards a higher level
To treat Hb to a higher level a choice can be made to correct Hb when it has dropped to a very low level after renal disease has reached an advanced stage or alternatively to prevent anaemia in an early stage of renal disease In an analysis of the normal hematocrit trial Macdougall and Ritz suggest the latter This is the main purpose of this trial
Treatment with Epoetin alfa also makes patients feel better physically when their exercise capacity improves During treatment with Epoetin alfa several secondary effects may simultaneously influence the maximal exercise capacity after correction of the anaemia The improved well-being may result in an increase in physical activity and exercise capacity can be further improved by such conditioning The improved oxygen transport after correction of anaemia reverses the circulatory adaptation to hypoxia and most studies have shown a decrease in cardiac output at rest and an increase in peripheral resistance However approximately one-third of chronic renal failure patients treated with Epoetin alfa have episodes of hypertension and may require increased doses of anti-hypertensive medication
This prospective study will assess whether maintaining Hb levels at normal or sub-normal levels can influence the health status left ventricular mass and quality of life QoL of early renal insufficiency subjects without additional safety concerns The patients will receive Epoetin Alfa as subcutaneous or intravenous injections in variable dosages for a maximum of 42 months
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