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)

Study Overview
=================
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.

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

Conditions
-----------------
Anemia, Secondary Hyperparathyroidism

Intervention / Treatment
-----------------
* Drug: Cinacalcet


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cinacalcet<br>Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was > 31.8 pmol/L (300 pg/mL) unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was < 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase. | Drug: Cinacalcet<br>* Cinacalcet tablets<br>* Other names: Sensipar®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. | Weeks 17 to 23 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL | Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase. | Weeks 17 to 23 | 
| Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) | The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels. | Weeks 17 to 23 | 
| Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L | The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase. | Weeks 17 to 23 | 
| Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L | The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase. | Weeks 17 to 23 | 
| Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL | The number of participants who achieved a mean C-reactive protein (CRP) level of < 0.6 mg/dL during the effectiveness assessment phase. | Weeks 17 to 23 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Intact Parathyroid Hormone (iPTH), Secondary Hyperparathyroidism (SHPT)