SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism
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ClinicalTrials.gov Identifier: NCT00117052 |
Recruitment Status :
Completed
First Posted : July 4, 2005
Last Update Posted : May 23, 2013
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Condition or disease | Intervention/treatment | Phase |
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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 |
Arm | Intervention/treatment |
---|---|
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. |
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. |
- Number of subjects with PTH less than or equal to 300pg/mL [ Time Frame: 21 week dose optimisation phase ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |

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
Study Director: | MD | Amgen |
Publications of Results:
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT00117052 |
Other Study ID Numbers: |
20040143 |
First Posted: | July 4, 2005 Key Record Dates |
Last Update Posted: | May 23, 2013 |
Last Verified: | May 2013 |
Clinical trial Amgen Secondary HyperParaThyroidism (SHPT) Dialysis |
End Stage Renal Disease (ESRD) KDOQI Cinacalcet |
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 Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Calcimimetic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |