Clinical trial NCT00431496: 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)
Official title: A Study To Assess Achievement of NKF K/DOQI Targets Using Sensipar (Cinacalcet) in Australian Subjects With End Stage Renal Disease (ESRD) Who Are Being Treated With Aranesp for Anaemia Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Secondary Hyperparathyroidism
Keywords: Anemia
Intact Parathyroid Hormone (iPTH)
Secondary Hyperparathyroidism (SHPT)
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-02-05
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2
timeFrame: Weeks 17 to 23
Secondary outcomes:
measure: Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL
timeFrame: Weeks 17 to 23
measure: Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2)
timeFrame: Weeks 17 to 23
measure: Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L
timeFrame: Weeks 17 to 23
measure: Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L
timeFrame: Weeks 17 to 23
measure: Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL
timeFrame: Weeks 17 to 23
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: