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)

NCT02859220 | Completed

• 1 other identifier: BRD/05/12-C
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

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 (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.

Conditions

Hemodialysis Patients

Keywords

hemodialysis; PTH

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

group 1

OTHER

group 1 : Roche Elecsys intact PTH

Other: Determination of PTH following

group 2

OTHER

group 2 : PTH 1-84 complete (PAC) report and CAP / PTH 7-84 (CIP), Duo PTH IRMA Scantibodies

Other: Determination of PTH following:

Interventions

Determination of PTH following: OTHER

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.

group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: August 9, 2016
• Study Start: January 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 9, 2016

Record last verified: 2011-06