E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events
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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: Sensipar (Cinacalcet HCl) 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 HCl Therapy to Lower CardioVascular Events |
- Time to the composite event comprising all-cause mortality or non-fatal cardiovascular events (MI, hospitalization for unstable angina, HF, or peripheral vascular event) [ Time Frame: estimated 2.5 to 4 years ] [ Designated as safety issue: Yes ]
- Time to all-cause mortality [ Time Frame: estimated 2.5 to 4 years ] [ Designated as safety issue: No ]
- Time to cardiovascular mortality [ Time Frame: estimated 2.5 to 4 years ] [ Designated as safety issue: No ]
- Time to fatal and non-fatal MI [ Time Frame: estimated 2.5 to 4 years ] [ Designated as safety issue: Yes ]
- Time to fatal and non-fatal hospitalization for unstable angina [ Time Frame: estimated 2.5 to 4 years ] [ Designated as safety issue: Yes ]
- Time to fatal and non-fatal HF event [ Time Frame: estimated 2.5 to 4 years ] [ Designated as safety issue: Yes ]
- Time to fatal and non-fatal peripheral vascular event [ Time Frame: estimated 2.5 to 4 years ] [ Designated as safety issue: Yes ]
- Time to fatal and non-fatal stroke [ Time Frame: estimated 2.5 to 4 years ] [ Designated as safety issue: Yes ]
- Time to bone fracture [ Time Frame: estimated 2.5 to 4 years ] [ Designated as safety issue: Yes ]
- Time to parathyroidectomy [ Time Frame: estimated 2.5 to 4 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 3883 |
| Study Start Date: | September 2006 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | March 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 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.
Drug: Sensipar (Cinacalcet HCl)
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.
|
| 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 |
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. 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
Contacts and Locations More Information
Additional Information:
Publications:
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 |
| Last Updated: | September 27, 2012 |
| 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 Kidney Failure, Chronic |
Parathyroid Diseases Endocrine System Diseases Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 16, 2013