A Research Study for Patients With End-Stage Renal Disease (ESRD)
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ClinicalTrials.gov Identifier: NCT00110890 |
Recruitment Status :
Completed
First Posted : May 17, 2005
Results First Posted : March 7, 2011
Last Update Posted : March 7, 2011
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Condition or disease | Intervention/treatment | Phase |
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End Stage Renal Disease | Drug: cinacalcet Other: Standard of care | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 552 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Randomised Study Using Cinacalcet to Improve Achievement of Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With ESRD |
Study Start Date : | May 2004 |
Actual Primary Completion Date : | April 2005 |
Actual Study Completion Date : | September 2007 |

Arm | Intervention/treatment |
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No Intervention: Standard of care
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets.
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Other: Standard of care
Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator's practice in an attempt to achieve the K/DOQI PTH, serum calcium, phosphorus, and Ca x P treatment targets. |
Cinacalcet
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on iPTH values.
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Drug: cinacalcet
Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. |
- Number of Participants With Mean PTH ≤ 300 pg/mL [ Time Frame: Efficacy Assessment Phase (weeks 17 to 23) ]Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase
- Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL [ Time Frame: Efficacy Assesment Phase (weeks 17-23) ]Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 and intact parathyroid hormone (iPTH) ≤ 300 pg/mL during the efficacy assessment phase
- Number of Participants With Mean Ca x P < 55 mg^2/dL^2 [ Time Frame: Efficacy Assessment Phase (weeks 17 to 23) ]Number of participants with mean calcium x phosphorus (Ca x P) < 55 mg^2/dL^2 during the efficacy assessment phase
- Number of Participants With Mean Serum Ca < 9.5 mg/dL [ Time Frame: Efficacy Assessment Phase (weeks 17-23) ]Number of participants with mean serum calcium (Ca) < 9.5 mg/dL during the efficacy assessment phase
- Number of Participants With Mean Serum P < 5.5 mg/dL [ Time Frame: Efficacy Assessment Phase (weeks 17 to 23) ]Number of participants with mean serum phosphorus (P) < 5.5 mg/dL during the efficacy assessment phase

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ESRD patients requiring maintenance dialysis (haemodialysis, haemodiafiltration, haemofiltration, or peritoneal dialysis) for at least 1 month
- The mean of 2 iPTH determinations within 21 days before randomization and drawn at least 2 days apart must be greater than or equal to 300 pg/mL (31.8 pmol/L) and less than 800 pg/mL (84.8 pmol/L). If biPTH is determined, the mean levels must be greater than or equal to 150 pg/mL (15.9 pmol/L) and less than 410 pg/mL (43.5 pmol/L)
- The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same day as the PTH determinations 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
- Have had a parathyroidectomy in the 6 months before day 1
- Have received vitamin D therapy for less than 21 days before day 1 or required a change in prescribed vitamin D brand or dose within 21 days before day 1. If subjects are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for the 21 days 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 tricyclic antidepressant amitriptyline is permitted. - Experienced a myocardial infarction within 3 months prior to day 1
- Are currently enrolled in, or have not yet completed at least 30 days before day 1, other invasive investigational device or investigational drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable)
- Have a gastrointestinal disorder that may be associated with impaired absorption or orally administered medications or an inability to swallow tablets

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): NCT00110890
Study Director: | MD | Amgen |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Global Development Leader, Amgen Inc. |
ClinicalTrials.gov Identifier: | NCT00110890 |
Other Study ID Numbers: |
20030187 |
First Posted: | May 17, 2005 Key Record Dates |
Results First Posted: | March 7, 2011 |
Last Update Posted: | March 7, 2011 |
Last Verified: | February 2011 |
Secondary HyperParaThyroidism (SHPT) Dialysis, End Stage Renal Disease (ESRD) KDOQI, Cinacalcet Clinical Trial, 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 |