A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)
Condition: Anemia; Secondary Hyperparathyroidism
MeSH terms: Kidney Failure, Chronic; Anemia; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Cinacalcet
Intervention description: Cinacalcet tablets
Intervention MeSH terms: Cinacalcet
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anemia; Intact Parathyroid Hormone (iPTH); Secondary Hyperparathyroidism (SHPT)

Summary:

      The purpose of this study is to show that the use of cinacalcet in patients with End Stage
      Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium
      phosphorous product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with ESRD requiring maintenance dialysis (haemodialysis, haemodiafiltration,
             haemofiltration, or peritoneal dialysis) for at least 1 month

          -  Being treated with Aranesp for anaemia management and have stabilised haemoglobin (Hb)
             levels. Hb stabilisation is defined as two consecutive Hb measurements during the
             screening period (that must include the most recent assessment) above 110 g/L.

          -  Males or females > 18 years of age at the time of informed consent

          -  Patients participating in this study must agree to use, in the opinion of the
             principal investigator, highly effective contraceptive measures throughout the study.
             Females must have a negative serum pregnancy test within 21 days before day 1 if they
             are of child-bearing potential

          -  The mean of 2 Intact parathyroid hormone (iPTH) determinations within 21 days before
             study day 1 and drawn at least 2 days apart must be > 31.8 pmol/L (300 pg/mL) and <
             84.8 pmol/L (800 pg/mL)

          -  The mean of 2 serum calcium determinations (corrected for albumin) drawn on the same
             day as the PTH determinations must be > 2.1 mmol/L (8.4 mg/dL)

          -  Signed the Independent Ethics Committee (IEC) approved Informed Consent document,
             before ANY study specific procedures are initiated

        Exclusion Criteria:

          -  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 patients
             are not prescribed vitamin D therapy, they must remain free of vitamin D therapy for
             the 21 days before day 1

          -  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

          -  Hypersensitivity to Sensipar or any of its components

          -  Are currently breastfeeding

          -  Have had a parathyroidectomy in the 3 months before day 1

          -  Experienced a myocardial infarction within 3 months prior to day 1

          -  Have had a red blood cell transfusion 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 of
             orally administered medications or an inability to swallow tablets

          -  Have a disorder that would interfere with understanding and giving informed consent,
             or compliance with protocol requirements

          -  Have previously enrolled in this study or participated in other trials of Sensipar