An Open Label, Single Arm Study Using Sensipar to Improve Achievement of K/DOQI Targets in Patients With ESRD.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00431496
• Date of registration: 01/02/2007
• Primary sponsor: Amgen
• Public title: An Open Label, Single Arm Study Using Sensipar to Improve Achievement of K/DOQI Targets in Patients With ESRD.
• Scientific 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
• Date of first enrolment: October 2006
• Target sample size: 71
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00431496
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Australia

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects 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
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

- Subjects 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 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 subjects
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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anemia

Secondary Hyperparathyroidism

Intervention(s)

Drug: Cinacalcet

Primary Outcome(s)

Proportion of Participants With a Mean iPTH Value Between 150 and 300 pg/mL and a Ca x P Value < 55 mg2 /dL2 [Time Frame: Weeks 17 to 23]

Secondary Outcome(s)

Proportion of Participants Who Achieved a Mean Ca Value = 2.1 and = 2.37 mmol/L (8.4 to 9.5 mg/dL) [Time Frame: Weeks 17 to 23]

Proportion of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol2/L2 (55 mg2/dL2) [Time Frame: Weeks 17 to 23]

Proportion of Participants Who Achieved a Mean CRP < 0.6 mg/dL [Time Frame: Weeks 17 to 23]

Proportion of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL [Time Frame: Weeks 17 to 23]

Proportion of Participants Who Achieved a Mean Phosphorus Value = 1.13 and = 1.78 mmol/L (3.5 to 5.5 mg/dL) [Time Frame: Weeks 17 to 23]

Secondary ID(s)

20040196

To Target

Source(s) of Monetary Support

Please refer to primary and secondary sponsors