Cinacalcet for Secondary Hyperparathyroidism in Patients... | NCT00446329

Studies
Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

NCT00446329

Sponsor

Papageorgiou General Hospital

Status

Terminated

Last Update Posted

Oct 29, 2014Estimated

Enrollment

15Actual

Phase

Phase 4

Conditions

Secondary Hyperparathyroidism

Interventions

cinacalcet

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

due to financial problems

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 9, 2007

First Submission Date that Met QC Criteria

Mar 9, 2007

First Posted Date

Mar 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2014

Last Update Posted Date

Oct 29, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cinacalcet	Drug	Initiation dose of cinacalcet 30 mg/day. Titration every 2-3 weeks with a maximum dose of 180 mg/day.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients		one year period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Efstathios Mitsopoulos, MD	Papageorgiou General Hospital, Thessaloniki, Greece	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Papageorgiou General Hospital		Thessaloniki		56403	Greece

Condition Browse Module

MeSH Terms

ID	Term
D006962	Hyperparathyroidism, Secondary

Ancestor Terms

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069449	Cinacalcet

Ancestor Terms

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided