Trial record 1 of 1 for:    NCT00345839
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E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events (EVOLVE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00345839
First received: June 27, 2006
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis.


Condition Intervention Phase
Secondary Hyperparathyroidism
Chronic Kidney Disease
Drug: Cinacalcet
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event) [ Time Frame: From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event). Stratified by history of diabetes and country.


Secondary Outcome Measures:
  • Time to All-cause Mortality [ Time Frame: From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to All-cause Mortality. Stratified by history of diabetes and country.

  • Time to Myocardial Infarction [ Time Frame: From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Myocardial Infarction. Stratified by history of diabetes and country.

  • Time to Hospitalization for Unstable Angina [ Time Frame: From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.

  • Time to Heart Failure [ Time Frame: From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Heart Failure. Stratified by history of diabetes and country.

  • Time to Peripheral Vascular Event [ Time Frame: From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Peripheral Vascular Event. Stratified by history of diabetes and country.

  • Time to Cardiovascular Mortality [ Time Frame: From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Cardiovascular Mortality. Stratified by history of diabetes and country.

  • Time to Stroke [ Time Frame: From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Stroke. Stratified by history of diabetes and country.

  • Time to Bone Fracture [ Time Frame: From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Bone Fracture. Stratified by history of diabetes and country.

  • Time to Parathyroidectomy [ Time Frame: From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years ] [ Designated as safety issue: No ]
    Time to Parathyroidectomy. Stratified by history of diabetes and country.


Enrollment: 3883
Study Start Date: August 2006
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cinacalcet Drug: Cinacalcet
Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg daily (QD), once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.
Placebo Comparator: Placebo Drug: Placebo
Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg QD, once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.

Detailed Description:

Secondary HPT is common in people with CKD. Patients with secondary HPT often have high parathyroid hormone (PTH) levels and may develop large parathyroid glands in the neck. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. Other problems from secondary HPT may include increases in blood levels of calcium and phosphorus. These may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), or heart and lung problems. New evidence suggests that secondary HPT is associated with cardiovascular disease and increased death risk. The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events (having to do with the heart and its blood vessels) and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis. These events include death from any reason, heart attack and episodes where the heart does not get enough oxygen, peripheral vascular disease (narrowing of vessels that carry blood to the legs, arms, stomach or kidneys), and heart failure (a condition that occurs when the heart is unable to pump enough blood to meet the need's of the body's tissues)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion:≥ 18 years of age
  • Treated with maintenance hemodialysis - PTH ≥ 300 pg/mL (31.8 pmol/L)
  • serum calcium ≥ 8.4mg/dL (2.1 mmol/L)
  • Ca x P ≥ 45 mg2*/dL2 (3.63 mmol2/L2)

Exclusion Criteria: - Exclusion:

  • Parathyroidectomy in the 12 weeks before the date of informed consent
  • Received therapy with cinacalcet within 3 months of randomization
  • Hospitalization within 12 weeks of randomization for any of the following events: a. Myocardial ischemia b. Unstable angina c. Heart Failure (HF) (including any unplanned presentation to a health care facility that would require mechanical intervention [i.e., unplanned dialysis treatment]) d. Peripheral vascular disease (other than dialysis vascular access revision) e. Stroke
  • History of seizure within 12 weeks prior to randomization
  • Scheduled date for kidney transplant from a known living donor
  • Anticipated parathyroidectomy within 6 months after randomization

    • in all instances, the 2 refers to squared.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345839

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Chertow G, Block G, Correa-Rotter R, Drueke T, Floege J, Goodman W, Herzog C, Kubo Y, London G, Mahaffey K, Mix TC, Moe S, Trotman M, Wheeler D, Parfrey P. Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis. New England Journal of Medicine;2012;367:2482-2494.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00345839     History of Changes
Other Study ID Numbers: 20050182
Study First Received: June 27, 2006
Results First Received: June 6, 2013
Last Updated: July 11, 2014
Health Authority: CAN: HealthCanada
EU: Committee for Human Medicinal Products
Latin America/Russia: Ministry Of Health
United States: Food and Drug Administration

Keywords provided by Amgen:
Cinacalcet HCl
Cinacalcet
AMG 073
Sensipar
Mimpara
Calcimimetic
Hemodialysis
CKD
Secondary hyperparathyroidism (HPT)

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Endocrine System Diseases
Parathyroid Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014