SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
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| ClinicalTrials.gov Identifier: NCT00117052 |
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Recruitment Status :
Completed
First Posted : July 4, 2005
Last Update Posted : May 23, 2013
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Secondary Hyperparathyroidism End Stage Renal Disease | Drug: cinacalcet | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 673 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | SENSOR: Study to InvestigatE Cinacalcet TreatmeNt in Haemodialysis Patients With SecOndary HyperparathyRoidism |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | November 2005 |
| Actual Study Completion Date : | February 2006 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: During dialysis visit
Cinacalcet is given during the dialysis visit
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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. |
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Active Comparator: Post-dialysis meal
Cinacalcet is administered with a post-dialysis meal
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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. |
Primary Outcome Measures :
- Number of subjects with PTH less than or equal to 300pg/mL [ Time Frame: 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 [ Time Frame: Dose Optimisation phase 21 weeks ]
- Safety of cinacalcet [ Time Frame: 21 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117052
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Additional Information:
Publications of Results:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00117052 History of Changes |
| Other Study ID Numbers: |
20040143 |
| First Posted: | July 4, 2005 Key Record Dates |
| Last Update Posted: | May 23, 2013 |
| Last Verified: | May 2013 |
Keywords provided by Amgen:
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Clinical trial Amgen Secondary HyperParaThyroidism (SHPT) Dialysis |
End Stage Renal Disease (ESRD) KDOQI Cinacalcet |
Additional relevant MeSH terms:
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Neoplasm Metastasis Kidney Diseases Kidney Failure, Chronic Hyperparathyroidism Hyperparathyroidism, Secondary Neoplastic Processes Neoplasms Pathologic Processes Urologic Diseases |
Renal Insufficiency, Chronic Renal Insufficiency Parathyroid Diseases Endocrine System Diseases Cinacalcet Hydrochloride Calcimimetic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |