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Study Complete
Sponsor ID
20040143

SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients with Secondary Hyperparathyroidism

Sponsor ID
20040143
Clinicaltrials.gov ID
NCT00117052
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to demonstrate that the efficacy of cinacalcet when co-administered with the first meal after dialysis is comparable (non-inferior) to the efficacy of cinacalcet when administered during the dialysis study visit.

Additional Study Details

Phase
Phase 3
Product
cinacalcet hcl
Type
Interventional
Masking
None (Open Label)
Enrollment
673
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of subjects with PTH less than or equal to 300pg/mL

Timeframe: 21 week dose optimisation phase

Secondary Outcome Measures

Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes

Timeframe: Dose Optimisation phase 21 weeks

Safety of cinacalcet

Timeframe: 21 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Hyperparathyroidism
    • Show more
  • Kidney Disease
    • Sex
    All
    Trial Dates
    Oct 2004 - Nov 2005
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment - An iPTH determination within 14 days before randomisation must be greater than or equal to 300 pg/mL (biPTH greater than or equal to 150 pg/mL) - A serum calcium determination (corrected for calcium) within 14 days before randomisation must be greater than or equal to 8.4 mg/dL [2.1 mmol/L]
    Exclusion Criteria:
    - Have an unstable medical condition, defined as having been hospitalised, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Are currently breast-feeding - Are performing peritoneal dialysis - Have had a parathyroidectomy in the 3 months before day 1 - Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets