Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00446329
NCT00446329
Terminated
Phase 4

Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

Papageorgiou General Hospital1 site in 1 country15 target enrollmentJuly 2006
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsSecondary Hyperparathyroidism
Drugscinacalcet

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Secondary Hyperparathyroidism
Sponsor
Papageorgiou General Hospital
Enrollment
15
Locations
1
Primary Endpoint
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients
Status
Terminated
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day.

The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to control secondary hyperparathyroidism without simultaneous administration of other vitamin D compounds.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Papageorgiou General Hospital
Responsible Party
Principal Investigator
Principal Investigator

Efstathios Mitsopoulos

Nephrologist

Papageorgiou General Hospital

Eligibility Criteria

Inclusion Criteria

  • •Age older than 18 yrs
  • •On hemodialysis for at least 3 months (thrice weekly)
  • •iPTH \>300pg/ml or histological evidence of secondary hyperparathyroidism
  • •Calcium \> 8.1 mg/dl

Exclusion Criteria

  • •Unstable clinical condition

Outcomes

Primary Outcomes

Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients

Time Frame: one year period

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 1
Effect of Cinacalcet on Parathyroid Hormone Secretion in Children and Adolescents With Hypophosphatemic RicketsHypophosphatemic Rickets, X-Linked Dominant
NCT00195936Children's Mercy Hospital Kansas City8
Terminated
Not Applicable
Using Cinacalcet to Treat the Hypophosphatemia of Early Kidney TransplantHypophosphatemiaRenal Transplant
NCT01011114Montefiore Medical Center40
Completed
Not Applicable
Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer DiagnosisProstate Cancer
NCT02397629Wake Forest University Health Sciences62
Completed
Not Applicable
Oral Peptones Load in Normocalcemic and Hypercalcemic Primary Hyperparathyroidism and Healthy SubjectsHyperparathyroidismHypercalcemia
NCT01042626University of Eastern Piedmont60
Completed
Phase 1
Safety Study of Parathyroid Hormone in Patients Needing Additional Stem Cell Mobilization.LymphomaMultiple MyelomaAcute Myelogenous Leukemia
NCT00299780Massachusetts General Hospital12