Cinacalcet Study to Reach Kidney Disease Outcomes Quality Initiative (K/DOQI) Levels
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00113958 |
Recruitment Status :
Completed
First Posted : June 13, 2005
Last Update Posted : May 13, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
End Stage Renal Disease | Drug: Cinacalcet | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Cinacalcet Open Label Study to Reach K/DOQI Levels |

- Secondary hyperparathyroidism in people with kidney failure.
- Uncontrolled secondary hyperparathyroidism

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: - Men and women must agree to use highly effective contraceptive measures throughout the study - Prescribed hemodialysis for at least 3 months before study day 1 - Must be receiving IV vitamin D sterols during the 30 days before day
1 (greater than 2 µg of paricalcitol, greater than 1 µg of doxercalciferol, or greater than 0.5 µg of calcitriol per dialysis treatment) - The mean of 2 biPTH determinations obtained from the central laboratory must be greater than or equal to 80 pg/mL and less than or equal to 160 pg/mL - The mean 2 albumin corrected serum calcium determinations obtained from the central laboratory must be greater than or equal to 8.4 mg/dL - The mean of two Ca x P calculations, based on corrected serum calcium and serum phosphorus determinations obtained from the central laboratory must be greater than 55 mg²/dL Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - Pregnant or nursing females - Parathyroidectomy in the 12 weeks before day 1 - Received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme CYP2D6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine and most tricyclic antidepressants). The antidepressant amitriptyline is permitted - Received, within 21 days before day 1, therapy with medications that are potent inhibitors (e.g., ketoconazole, itraconazole and erythromycin) or inducers (e.g., rifampin and St. John's Wort) of the enzyme CYP3A4. Phenytoin, phenobarbital and carbamazepine are also potent inducers of this enzyme. However, subjects on a stable dose of any of these anti-convulsants at baseline, with no evidence of seizure activity in the past 2 months may be eligible for the study - Experienced a myocardial infarction within 12 weeks prior to day 1 - Currently enrolled in, or have not yet completed at least 30 days since ending other investigational device or drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable) - Current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets - Participated in other studies with cinacalcet HCl - Disorder that would interfere with the understanding and giving of informed consent or compliance with protocol requirements

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): NCT00113958
Study Director: | MD | Amgen |
Publications of Results:
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT00113958 |
Other Study ID Numbers: |
20020389 |
First Posted: | June 13, 2005 Key Record Dates |
Last Update Posted: | May 13, 2013 |
Last Verified: | May 2013 |
End Stage Renal Disease (ESRD) secondary hyperparathyroidism (SHPT) hemodialysis biPTH AMG 073, Amgen |
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Cinacalcet |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Calcimimetic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |