Ignite Creation Date:
2024-05-06 @ 8:55 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02859220
Status:
COMPLETED
Last Update Posted:
2016-08-09
First Post:
2011-06-29
Brief Title:
Study of the Influence of Dosages of 1-84 and 7-84 Fragments of Parathyroid Hormone Compared to Conventional Dosage on the Balance of Calcium and Phosphate in Hemodialysis PTH
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Study of the Influence of Dosages of 1-84 and 7-84 Fragments of PTH Compared to Conventional Dosage on the Balance of Calcium and Phosphate in Hemodialysis
Status:
COMPLETED
Status Verified Date:
2011-06
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:
PTH
Brief Summary:
This study included 80 patients with end stage renal disease requiring dialysis treatment to evaluate two techniques for the determination of parathyroid hormone PTH
Objective To evaluate whether the monitoring of hemodialysis patients by measurement of PTH 1-84 Complete CAP cyclase activating PTH and the ratio 1-84 PTH CAP7-84 PTH CIP cyclase inactivating PTH with kit Duo PTH Immunoradiometric Scantibodies allows an improvement in the therapeutic management of abnormal calcium and phosphate with a better match to the targets of current international recommendations followed by the conventional intact PTH assay
Primary endpoint
For each patient a score will be awarded based on the number of criteria including calcium phosphorus and calcium phosphate product in the target international guidelines 0-1-2 or 3
The primary endpoint will be the average scores in both groups at the beginning and the end of the study
Main secondary endpoints
Changes in the number of patients responding to international guidelines for each of the three parameters studied serum phosphate corrected calcium phosphorus product in the 2 groups
Evolution of Elecsys intact PTH Roche in the 2 groups
Salaries and changes in the number of drugs to normalize the phospho-calcium balance in each group received
cardiovascular events morbidity and cardiovascular mortality
Total mortality
Statistical analysis
This is a randomized two parallel arms The investigators will compare the average number of criteria on calcium and phosphate in the target according to a Mann-Whitney The analysis will be performed with the software Splus
Objective To evaluate whether the monitoring of hemodialysis patients by measurement of PTH 1-84 Complete CAP cyclase activating PTH and the ratio 1-84 PTH CAP7-84 PTH CIP cyclase inactivating PTH with kit Duo PTH Immunoradiometric Scantibodies allows an improvement in the therapeutic management of abnormal calcium and phosphate with a better match to the targets of current international recommendations followed by the conventional intact PTH assay
Primary endpoint
For each patient a score will be awarded based on the number of criteria including calcium phosphorus and calcium phosphate product in the target international guidelines 0-1-2 or 3
The primary endpoint will be the average scores in both groups at the beginning and the end of the study
Main secondary endpoints
Changes in the number of patients responding to international guidelines for each of the three parameters studied serum phosphate corrected calcium phosphorus product in the 2 groups
Evolution of Elecsys intact PTH Roche in the 2 groups
Salaries and changes in the number of drugs to normalize the phospho-calcium balance in each group received
cardiovascular events morbidity and cardiovascular mortality
Total mortality
Statistical analysis
This is a randomized two parallel arms The investigators will compare the average number of criteria on calcium and phosphate in the target according to a Mann-Whitney The analysis will be performed with the software Splus
Detailed Description:
None
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