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

Phase 1

• Conditions: Secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis

• Registration Number: EUCTR2004-002310-10-ES
• Lead Sponsor: Amgen Development Europe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-11-10
• Study Completion: 2005-11-10
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

- CKD patients requiring dialysis (HD, HDF, HF) for at least 1 month before enrolment
- Males or females = 18 years of age at the time of informed consent.
- Men and women participating in this study must agree to use, in the opinion of the principal investigator, highly effective contraceptive measures throughout the study. Females must have a negative serum pregnancy test (or definitive evidence to demonstrate lack of pregnancy) within 30 days before randomisation, unless there is a definite history of amenorrhoea.
- An iPTH determination within 14 days before randomisation must be = 300 pg/mL (biPTH = 150 pg/mL).
- A serum calcium determination (corrected for calcium) within 14 days before randomisation must be = 8.4 mg/dL [2.1 mmol/L].
- Signed the Independent Ethics Committee (IEC) approved Informed Consent document, before any study specific procedures are initiated

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.
- Are currently enrolled in, or have not yet completed at least 30 days before day 1 other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable).
- Have a gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets.
- Have a disorder that would interfere with understanding and giving informed consent or compliance with protocol requirements

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified