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

Amgen673 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

673

Conditions

Secondary Hyperparathyroidism End Stage Renal Disease

Interventions

cinacalcetDRUG

All eligible subjects were assigned to receive once daily oral doses of cinacalcet, but were randomised in a 1:1 ratio to receive the drug either with the first meal after dialysis or during the dialysis visit on dialysis days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 21 week dose optimisation phase

Secondary Outcomes

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

Time frame: Dose Optimisation phase 21 weeks

Safety of cinacalcet

Time frame: 21 weeks

Data from ClinicalTrials.gov

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