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)

NCT ID: NCT00431496

Last Updated: 2013-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-10-31

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.

Conditions

Anemia; Secondary Hyperparathyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cinacalcet

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.

Group Type: EXPERIMENTAL

Cinacalcet

Intervention Type: DRUG

Cinacalcet tablets

Interventions

Cinacalcet

Cinacalcet tablets

Intervention Type: DRUG

Other Intervention Names

Sensipar®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

To Target

Identifier Type: -

Identifier Source: secondary_id

20040196

Identifier Type: -

Identifier Source: org_study_id