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)

Hemodialysis Patients Clinical Trial

— PTH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859220
• Other study ID #: BRD/05/12-C
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: August 3, 2016
• Start date: January 2006
• Est. completion date: January 2011

Study information

• Verified date: June 2011
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: french Health Products Safety Agency
• Study type: Interventional

Clinical Trial 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 (CAP)/7-84 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• replacement therapy by hemodialysis for at least three months in the hemodialysis center of Nantes University Hospital,

• intact PTH = 100 pg / mL during the visit of inclusion.

Exclusion Criteria:

• intact PTH <100 pg / mL during the visit of inclusion

• Life expectancy estimated at less than one year at the time of inclusion, because of a disease diagnosed prior to the initiation of the study,

• bone pathology diagnosed prior to the initiation of the study that interfere with calcium and phosphate metabolism (myeloma, Paget ...).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Other:
• Determination of PTH following
Determination of PTH following: in group 1: intact PTH Elecsys Roche
• Determination of PTH following:
PTH 1-84 complete (PAC) report and CAP / CIP, the package "Duo PTH IRMA Scantibodies." The CIP is obtained by calculating the difference between total intact PTH and PTH 1-84 in the kit used.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improving the therapeutic management of calcium and phosphate abnormalities by conventional PTH	Show that patients receiving a dose of complete PTH 1-84 (CAP) and the ratio PTH 1-84/7-84 more easily reach the objectives international guidelines on the three following parameters calcium and phosphate: phosphorus, corrected calcium and phosphorus product.; 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.	one year	No