E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events (EVOLVE)
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| ClinicalTrials.gov Identifier: NCT00345839 |
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Recruitment Status :
Completed
First Posted : June 29, 2006
Results First Posted : January 22, 2014
Last Update Posted : April 3, 2019
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Secondary Hyperparathyroidism Chronic Kidney Disease | Drug: Cinacalcet Drug: Placebo | Phase 3 |
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)
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3883 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events |
| Actual Study Start Date : | August 22, 2006 |
| Actual Primary Completion Date : | April 10, 2012 |
| Actual Study Completion Date : | April 10, 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| 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. |
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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]Time to Parathyroidectomy. Stratified by history of diabetes and country.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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Anticipated parathyroidectomy within 6 months after randomization
- in all instances, the 2 refers to squared.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345839
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00345839 |
| Other Study ID Numbers: |
20050182 |
| First Posted: | June 29, 2006 Key Record Dates |
| Results First Posted: | January 22, 2014 |
| Last Update Posted: | April 3, 2019 |
| Last Verified: | April 2019 |
Keywords provided by Amgen:
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Cinacalcet HCl Cinacalcet AMG 073 Sensipar Mimpara |
Calcimimetic Hemodialysis CKD Secondary hyperparathyroidism (HPT) |
Additional relevant MeSH terms:
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Kidney Diseases Renal Insufficiency, Chronic Hyperparathyroidism Hyperparathyroidism, Secondary Urologic Diseases Renal Insufficiency Parathyroid Diseases |
Endocrine System Diseases Cinacalcet Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Calcimimetic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |