SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00117052
First received: June 30, 2005
Last updated: May 21, 2013
Last verified: May 2013
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Number of subjects with PTH less than or equal to 300pg/mL [ Time Frame: 21 week dose optimisation phase ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in Calcium (Ca), Phosphor (P), Ca X P, KDOQI guidelines, Rate of Nausea and Vomiting Aes [ Time Frame: Dose Optimisation phase 21 weeks ] [ Designated as safety issue: No ]
- Safety of cinacalcet [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: During dialysis visit
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.
|
|
Active Comparator: Post-dialysis meal
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00117052
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117052
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00117052 History of Changes |
| Other Study ID Numbers: | 20040143 |
| Study First Received: | June 30, 2005 |
| Last Updated: | May 21, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Amgen:
|
Clinical trial Amgen Secondary HyperParaThyroidism (SHPT) Dialysis |
End Stage Renal Disease (ESRD) KDOQI Cinacalcet |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Hyperparathyroidism Hyperparathyroidism, Secondary Neoplastic Processes Neoplasms Pathologic Processes |
Urologic Diseases Renal Insufficiency Parathyroid Diseases Endocrine System Diseases Cinacalcet Hydrochloride Calcimimetic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2016