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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00117052 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Secondary Hyperparathyroidism End Stage Renal Disease |
Drug: cinacalcet |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism |
| Enrollment: | 673 |
| Study Start Date: | September 2004 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
During dialysis visit: Active Comparator
Cinacalcet is given during the dialysis visit
|
Drug: cinacalcet
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.
|
|
Post-dialysis meal: Active Comparator
Cinacalcet is administered with a post-dialysis meal
|
Drug: cinacalcet
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 97 Study Locations| Study Director: | MD | Amgen |
More Information
| Responsible Party: | Amgen Inc. ( Global Development Leader ) |
| Study ID Numbers: | 20040143 |
| Study First Received: | June 30, 2005 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00117052 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Clinical trial Amgen Secondary HyperParaThyroidism (SHPT) Dialysis |
End Stage Renal Disease (ESRD) KDOQI Cinacalcet |
|
Parathyroid Diseases Renal Insufficiency Kidney Failure, Chronic Endocrine System Diseases Hyperparathyroidism, Secondary Neoplastic Processes Neoplasms |
Pathologic Processes Hyperparathyroidism Urologic Diseases Renal Insufficiency, Chronic Neoplasm Metastasis Kidney Diseases Kidney Failure |
