A Research Study for Patients With End-Stage Renal Disease (ESRD)

Study Description

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Brief Summary:

The purpose of this study is to evaluate the ability of a treatment strategy, that includes cinacalcet for the management of secondary hyperparathyroidism, to control parathyroid hormone (PTH) compared with the standard of care.

Condition or disease	Intervention/treatment	Phase
End Stage Renal Disease	Drug: cinacalcet; Other: Standard of care	Phase 4

Study Design

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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

Arms and Interventions

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Arm	Intervention/treatment
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.	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.	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.

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Sponsors and Collaborators

Amgen

Investigators

Study Director:	MD	Amgen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

AmgenTrials clinical trials website 

FDA-approved Drug Labeling 

Publications of Results:

Messa P, Macário F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazão JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Wilkie M, Zani VJ, Molemans B, Carter D, Locatelli F. The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008 Jan;3(1):36-45. doi: 10.2215/CJN.03591006.

Wilkie M, Pontoriero G, Macário F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazão JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Zani VJ, Carter D, Messa P. Impact of vitamin D dose on biochemical parameters in patients with secondary hyperparathyroidism receiving cinacalcet. Nephron Clin Pract. 2009;112(1):c41-50. doi: 10.1159/000212102. Epub 2009 Apr 10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Frazão JM, Braun J, Messa P, Dehmel B, Mattin C, Wilkie M. Is serum phosphorus control related to parathyroid hormone control in dialysis patients with secondary hyperparathyroidism? BMC Nephrol. 2012 Aug 3;13:76. doi: 10.1186/1471-2369-13-76.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00110890 History of Changes
Other Study ID Numbers:	20030187
First Posted:	May 17, 2005
Results First Posted:	March 7, 2011
Last Update Posted:	March 7, 2011
Last Verified:	February 2011

Keywords provided by Amgen:

Secondary HyperParaThyroidism (SHPT); Dialysis, End Stage Renal Disease (ESRD); KDOQI, Cinacalcet; Clinical Trial, Amgen

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency	Cinacalcet Hydrochloride; Calcimimetic Agents; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs