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)

NCT00431496 | Completed Phase 4 Results

• 2 other identifiers: 20040196To Target
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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

Keywords

Anemia; Intact Parathyroid Hormone (iPTH); Secondary Hyperparathyroidism (SHPT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL

  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)

  Weeks 17 to 23

• Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L

  Weeks 17 to 23

• Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L

  Weeks 17 to 23

• Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL

  Weeks 17 to 23

Study Arms (1)

Cinacalcet

EXPERIMENTAL

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

Interventions

Cinacalcet DRUG

Cinacalcet tablets

Also known as: Sensipar®

Cinacalcet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anemia; Hyperparathyroidism, Secondary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2007
• First Posted: February 5, 2007
• Study Start: September 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: April 24, 2013
• Results First Posted: July 13, 2011

Record last verified: 2013-04