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Completed

NCT Number: NCT00110890

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-Label, Randomised Study Using Cinacalcet to Improve Achievement of Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With ESRD

Important dates

Study start
2004
Primary completion
2005
Study completion
2007
First posted
May 17, 2005
Registry last updated
Mar 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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