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

NCT00110890 | Completed Phase 4 Results

• 1 other identifier: 20030187
• Study Type: interventional
• Target: 552
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Renal Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Mean PTH ≤ 300 pg/mL

  Number of participants with mean parathyroid hormone (PTH) ≤ 300 pg/mL during the efficacy assessment phase

  Efficacy Assessment Phase (weeks 17 to 23)

Secondary Outcomes (4)

• Number of Participants With Mean Ca x P < 55 mg^2/dL^2 and iPTH ≤ 300 pg/mL

  Efficacy Assesment Phase (weeks 17-23)

• Number of Participants With Mean Ca x P < 55 mg^2/dL^2

  Efficacy Assessment Phase (weeks 17 to 23)

• Number of Participants With Mean Serum Ca < 9.5 mg/dL

  Efficacy Assessment Phase (weeks 17-23)

• Number of Participants With Mean Serum P < 5.5 mg/dL

  Efficacy Assessment Phase (weeks 17 to 23)

Study Arms (2)

Standard of care

NO INTERVENTION

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

Cinacalcet

OTHER

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

Interventions

cinacalcet DRUG

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.

Cinacalcet

Standard of care OTHER

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.

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (3)

• Messa P, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao 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.

  PMID: 18178780 RESULT

• Wilkie M, Pontoriero G, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazao 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.

  PMID: 19365139 RESULT

• Frazao 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.

  PMID: 22863242 DERIVED

Related Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• FDA-approved Drug Labeling

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperparathyroidism, Secondary

Interventions

Cinacalcet; Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 16, 2005
• First Posted: May 17, 2005
• Study Start: May 1, 2004
• Primary Completion: April 1, 2005
• Study Completion: September 1, 2007
• Last Updated: March 7, 2011
• Results First Posted: March 7, 2011

Record last verified: 2011-02