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CompletedNCT00345839EVOLVEUpdated Nov 7, 2022Results posted

E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events

A Phase 3 interventional study of Cinacalcet and Placebo in Secondary Hyperparathyroidism and Chronic Kidney Disease, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-07.

Sponsored by Amgen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
3,883
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Secondary Hyperparathyroidism
  • Chronic Kidney Disease

Keywords

  • Cinacalcet HCl
  • Cinacalcet
  • AMG 073
  • Sensipar
  • Mimpara
  • Calcimimetic
  • Hemodialysis
  • CKD
  • Secondary hyperparathyroidism (HPT)
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 3,883 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
3,883 participants (actual)

Study arms

  • Experimental
    Cinacalcet

    Drug: Cinacalcet

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugCinacalcet

    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.

  • DrugPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)

    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.

    Time frame: From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years

Secondary outcomes

  1. Time to All-cause Mortality

    Time to All-cause Mortality. Stratified by history of diabetes and country.

    Time frame: From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years

  2. Time to Myocardial Infarction

    Time to Myocardial Infarction. Stratified by history of diabetes and country.

    Time frame: From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years

  3. Time to Hospitalization for Unstable Angina

    Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.

    Time frame: From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years

  4. Time to Heart Failure

    Time to Heart Failure. Stratified by history of diabetes and country.

    Time frame: From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years

  5. Time to Peripheral Vascular Event

    Time to Peripheral Vascular Event. Stratified by history of diabetes and country.

    Time frame: From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years

  6. Time to Cardiovascular Mortality

    Time to Cardiovascular Mortality. Stratified by history of diabetes and country.

    Time frame: From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years

  7. Time to Stroke

    Time to Stroke. Stratified by history of diabetes and country.

    Time frame: From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years

  8. Time to Bone Fracture

    Time to Bone Fracture. Stratified by history of diabetes and country.

    Time frame: From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years

  9. Time to Parathyroidectomy

    Time to Parathyroidectomy. Stratified by history of diabetes and country.

    Time frame: From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years

07

Results

Posted Jan 22, 2014

Participant flow

Participants were recruited from dialysis clinics and hospitals between August 2006 to Jan 2008 from 22 countries.

Participant flow — Overall Study
MilestoneCinacalcetPlacebo
Started19481935
Completed17991776
Not completed149159
Withdrew: Withdrawal by subject9198
Withdrew: Lost to follow-up5861

Outcome measures

PrimaryTime to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)

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.

Time frame:
From date of randomization until date of first confirmed primary composite endpoint event, assessed up to 5.4 years
Reported as:
Median · Months
Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)
MonthsCinacalcetPlacebo
Time to Primary Composite Endpoint (All-cause Mortality, Myocardial Infarction, Hospitalization for Unstable Angina, Heart Failure or Peripheral Vascular Event)55.0 (22.6 to NA)53.0 (19.1 to NA)
Statistical analysis
  • Cinacalcet vs Placebo · Log Rank · p = 0.112 (p-value\<0.044 considered significant)Stratified by history of diabetes and country. 2-sided test.
  • Cinacalcet vs Placebo · Regression, Cox · Hazard ratio (hr): 0.93 · 95% CI 0.85 to 1.02HR is cinacalcet vs placebo.
SecondaryTime to All-cause Mortality

Time to All-cause Mortality. Stratified by history of diabetes and country.

Time frame:
From date of randomization until date of confirmed all-cause mortality endpoint event, assessed up to 5.4 years
Reported as:
Median · Months
Time to All-cause Mortality
MonthsCinacalcetPlacebo
Time to All-cause MortalityNA (37.9 to NA)NA (31.6 to NA)
Statistical analysis
  • Cinacalcet vs Placebo · Log Rank · p = 0.249 (No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.)Stratified by history of diabetes and country. 2-sided test.
  • Cinacalcet vs Placebo · Regression, Cox · Hazard ratio (hr): 0.94 · 95% CI 0.85 to 1.04HR is cinacalcet vs placebo.
SecondaryTime to Myocardial Infarction

Time to Myocardial Infarction. Stratified by history of diabetes and country.

Time frame:
From date of randomization until date of first confirmed myocardial infarction endpoint event, assessed up to 5.4 years
Reported as:
Median · Months
Time to Myocardial Infarction
MonthsCinacalcetPlacebo
Time to Myocardial InfarctionNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Cinacalcet vs Placebo · Log Rank · p = 0.800 (No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.)Stratified by history of diabetes and country. 2-sided test.
  • Cinacalcet vs Placebo · Regression, Cox · Hazard ratio (hr): 0.97 · 95% CI 0.79 to 1.19HR is cinacalcet vs placebo.
SecondaryTime to Hospitalization for Unstable Angina

Time to Hospitalization for Unstable Angina. Stratified by history of diabetes and country.

Time frame:
From date of randomization until date of first confirmed hospitalization for unstable angina endpoint event, assessed up to 5.4 years
Reported as:
Median · Months
Time to Hospitalization for Unstable Angina
MonthsCinacalcetPlacebo
Time to Hospitalization for Unstable AnginaNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Cinacalcet vs Placebo · Log Rank · p = 0.283 (No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.)Stratified by history of diabetes and country. 2-sided test.
  • Cinacalcet vs Placebo · Regression, Cox · Hazard ratio (hr): 0.82 · 95% CI 0.58 to 1.18HR is cinacalcet vs placebo.
SecondaryTime to Heart Failure

Time to Heart Failure. Stratified by history of diabetes and country.

Time frame:
From date of randomization until date of first confirmed heart failure endpoint event, assessed up to 5.4 years
Reported as:
Median · Months
Time to Heart Failure
MonthsCinacalcetPlacebo
Time to Heart FailureNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Cinacalcet vs Placebo · Log Rank · p = 0.034 (No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.)Stratified by history of diabetes and country. 2-sided test.
  • Cinacalcet vs Placebo · Regression, Cox · Hazard ratio (hr): 0.82 · 95% CI 0.68 to 0.99HR is cinacalcet vs placebo.
SecondaryTime to Peripheral Vascular Event

Time to Peripheral Vascular Event. Stratified by history of diabetes and country.

Time frame:
From date of randomization until date of first confirmed peripheral vascular endpoint event, assessed up to 5.4 years
Reported as:
Median · Months
Time to Peripheral Vascular Event
MonthsCinacalcetPlacebo
Time to Peripheral Vascular EventNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Cinacalcet vs Placebo · Log Rank · p = 0.190 (No adjustments for multiple comparisons were made for the components of the primary composite endpoint since the purpose of these analyses is to show how each component contributes to the results of the composite.)Stratified by history of diabetes and country. 2-sided test.
  • Cinacalcet vs Placebo · Regression, Cox · Hazard ratio (hr): 0.87 · 95% CI 0.72 to 1.07HR is cinacalcet vs placebo.
SecondaryTime to Cardiovascular Mortality

Time to Cardiovascular Mortality. Stratified by history of diabetes and country.

Time frame:
From date of randomization until date of first confirmed cardiovascular mortality endpoint event, assessed up to 5.4 years
Reported as:
Median · Months
Time to Cardiovascular Mortality
MonthsCinacalcetPlacebo
Time to Cardiovascular MortalityNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Cinacalcet vs Placebo · Log Rank · p = 0.277 (No adjustments for multiple comparisons were made for this endpoint.)Stratified by history of diabetes and country. 2-sided test.
  • Cinacalcet vs Placebo · Regression, Cox · Hazard ratio (hr): 0.92 · 95% CI 0.80 to 1.07HR is cinacalcet vs placebo.
SecondaryTime to Stroke

Time to Stroke. Stratified by history of diabetes and country.

Time frame:
From date of randomization until date of first confirmed stroke endpoint event, assessed up to 5.4 years
Reported as:
Median · Months
Time to Stroke
MonthsCinacalcetPlacebo
Time to StrokeNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Cinacalcet vs Placebo · Log Rank · p = 0.607 (No adjustments for multiple comparisons were made for this endpoint.)Stratified by history of diabetes and country. 2-sided test.
  • Cinacalcet vs Placebo · Regression, Cox · Hazard ratio (hr): 1.07 · 95% CI 0.82 to 1.40HR is cinacalcet vs placebo.
SecondaryTime to Bone Fracture

Time to Bone Fracture. Stratified by history of diabetes and country.

Time frame:
From date of randomization until date of first confirmed bone fracture endpoint event, assessed up to 5.4 years
Reported as:
Median · Months
Time to Bone Fracture
MonthsCinacalcetPlacebo
Time to Bone FractureNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Cinacalcet vs Placebo · Log Rank · p = 0.218 (No adjustments for multiple comparisons were made for this endpoint.)Stratified by history of diabetes and country. 2-sided test.
  • Cinacalcet vs Placebo · Regression, Cox · Hazard ratio (hr): 0.89 · 95% CI 0.75 to 1.07HR is cinacalcet vs placebo.
SecondaryTime to Parathyroidectomy

Time to Parathyroidectomy. Stratified by history of diabetes and country.

Time frame:
From date of randomization until date of first confirmed parathyroidectomy endpoint event, assessed up to 5.4 years
Reported as:
Median · Months
Time to Parathyroidectomy
MonthsCinacalcetPlacebo
Time to ParathyroidectomyNA (NA to NA)NA (NA to NA)
Statistical analysis
  • Cinacalcet vs Placebo · Log Rank · p = <0.001 (No adjustments for multiple comparisons were made for this endpoint.)Stratified by history of diabetes and country. 2-sided test.
  • Cinacalcet vs Placebo · Regression, Cox · Hazard ratio (hr): 0.44 · 95% CI 0.36 to 0.54HR is cinacalcet vs placebo.

Adverse events

Collected over Average 24 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—1,351/1,923 (70.3%)1,220/1,923 (63.4%)
Cinacalcet—1,338/1,938 (69%)1,444/1,938 (74.5%)
Most frequent serious events
Showing 10 of 1,285
Most frequent serious events
EventPlaceboCinacalcet
PneumoniaInfections and infestations171/1923118/1938
SepsisInfections and infestations111/1923123/1938
Myocardial infarctionCardiac disorders105/1923109/1938
HyperkalaemiaMetabolism and nutrition disorders74/192397/1938
Cardiac failureCardiac disorders90/192374/1938
Cardiac failure congestiveCardiac disorders86/192364/1938
HyperparathyroidismEndocrine disorders86/192323/1938
Atrial fibrillationCardiac disorders68/192356/1938
Cerebrovascular accidentNervous system disorders66/192360/1938
Cardiac arrestCardiac disorders57/192360/1938
Most frequent other events
Showing 10 of 29
Most frequent other events
EventPlaceboCinacalcet
NauseaGastrointestinal disorders288/1923552/1938
VomitingGastrointestinal disorders247/1923482/1938
DiarrhoeaGastrointestinal disorders349/1923376/1938
DyspnoeaRespiratory, thoracic and mediastinal disorders188/1923226/1938
ArthralgiaMusculoskeletal and connective tissue disorders224/1923158/1938
CoughRespiratory, thoracic and mediastinal disorders185/1923225/1938
HeadacheNervous system disorders182/1923219/1938
Muscle spasmsMusculoskeletal and connective tissue disorders174/1923213/1938
HypocalcaemiaMetabolism and nutrition disorders20/1923206/1938
Pain in extremityMusculoskeletal and connective tissue disorders193/1923201/1938

Baseline characteristics

Age, Continuous
Age, Continuous(Years)CinacalcetPlaceboTotal
Mean54.8 ± 14.554.0 ± 14.254.4 ± 14.4
Sex: Female, Male
Sex: Female, Male(Participants)CinacalcetPlaceboTotal
Female8097691578
Male113911662305
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)CinacalcetPlaceboTotal
White or Caucasian112411162240
Black or African American409428837
Hispanic or Latino317310627
Asian473885
Japanese415
American Indian or Alaska Native5712
Native Hawaiian or Other Pacific Islander12921
Aborigine145
Other292251
History of Diabetes Stratification Factor
History of Diabetes Stratification Factor(Participants)CinacalcetPlaceboTotal
Diabetes6196141233
No Diabetes132913212650
Country stratification factor
Country stratification factor(Participants)CinacalcetPlaceboTotal
Argentina171170341
Australia7475149
Austria312960
Belgium5050100
Brazil151150301
Canada7373146
Denmark81119
France404080
Germany8181162
Hungary6667133
Ireland5611
Italy6968137
Mexico232245
Netherlands151429
Poland5957116
Portugal222143
Russia143140283
Spain403878
Sweden131023
Switzerland181937
United Kingdom8179160
United States7157151430
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Chertow GM, Correa-Rotter R, Block GA, Drueke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Wheeler DC, Parfrey PS. Baseline characteristics of subjects enrolled in the Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial. Nephrol Dial Transplant. 2012 Jul;27(7):2872-9. doi: 10.1093/ndt/gfr777. Epub 2012 Apr 23. PubMed 22529163 ↗
  • Chertow GM, Pupim LB, Block GA, Correa-Rotter R, Drueke TB, Floege J, Goodman WG, London GM, Mahaffey KW, Moe SM, Wheeler DC, Albizem M, Olson K, Klassen P, Parfrey P. Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE): rationale and design overview. Clin J Am Soc Nephrol. 2007 Sep;2(5):898-905. doi: 10.2215/CJN.04381206. Epub 2007 Aug 16. PubMed 17702710 ↗
  • EVOLVE Trial Investigators; Chertow GM, Block GA, Correa-Rotter R, Drueke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Trotman ML, Wheeler DC, Parfrey PS. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. N Engl J Med. 2012 Dec 27;367(26):2482-94. doi: 10.1056/NEJMoa1205624. Epub 2012 Nov 3. PubMed 23121374 ↗
  • Parfrey PS, Chertow GM, Block GA, Correa-Rotter R, Drueke TB, Floege J, Herzog CA, London GM, Mahaffey KW, Moe SM, Wheeler DC, Dehmel B, Trotman ML, Modafferi DM, Goodman WG. The clinical course of treated hyperparathyroidism among patients receiving hemodialysis and the effect of cinacalcet: the EVOLVE trial. J Clin Endocrinol Metab. 2013 Dec;98(12):4834-44. doi: 10.1210/jc.2013-2975. Epub 2013 Oct 9. PubMed 24108314 ↗
  • Floege J, Tsirtsonis K, Iles J, Drueke TB, Chertow GM, Parfrey P. Incidence, predictors and therapeutic consequences of hypocalcemia in patients treated with cinacalcet in the EVOLVE trial. Kidney Int. 2018 Jun;93(6):1475-1482. doi: 10.1016/j.kint.2017.12.014. Epub 2018 Mar 7. PubMed 29525393 ↗
  • Abdalla S, Montez-Rath ME, Parfrey PS, Chertow GM. The win ratio approach to analyzing composite outcomes: An application to the EVOLVE trial. Contemp Clin Trials. 2016 May;48:119-24. doi: 10.1016/j.cct.2016.04.001. Epub 2016 Apr 11. PubMed 27080930 ↗
  • Moe SM, Chertow GM, Parfrey PS, Kubo Y, Block GA, Correa-Rotter R, Drueke TB, Herzog CA, London GM, Mahaffey KW, Wheeler DC, Stolina M, Dehmel B, Goodman WG, Floege J; Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial Investigators*. Cinacalcet, Fibroblast Growth Factor-23, and Cardiovascular Disease in Hemodialysis: The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial. Circulation. 2015 Jul 7;132(1):27-39. doi: 10.1161/CIRCULATIONAHA.114.013876. Epub 2015 Jun 9. PubMed 26059012 ↗
  • Floege J, Kubo Y, Floege A, Chertow GM, Parfrey PS. The Effect of Cinacalcet on Calcific Uremic Arteriolopathy Events in Patients Receiving Hemodialysis: The EVOLVE Trial. Clin J Am Soc Nephrol. 2015 May 7;10(5):800-7. doi: 10.2215/CJN.10221014. Epub 2015 Apr 17. PubMed 25887067 ↗
  • Kubo Y, Sterling LR, Parfrey PS, Gill K, Mahaffey KW, Gioni I, Trotman ML, Dehmel B, Chertow GM. Assessing the treatment effect in a randomized controlled trial with extensive non-adherence: the EVOLVE trial. Pharm Stat. 2015 May-Jun;14(3):242-51. doi: 10.1002/pst.1680. Epub 2015 Apr 6. Erratum In: Pharm Stat. 2015 Jul-Aug;14(4):368. doi: 10.1002/pst.1694. PubMed 25851955 ↗
  • Parfrey PS, Drueke TB, Block GA, Correa-Rotter R, Floege J, Herzog CA, London GM, Mahaffey KW, Moe SM, Wheeler DC, Kubo Y, Dehmel B, Goodman WG, Chertow GM; Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial Investigators. The Effects of Cinacalcet in Older and Younger Patients on Hemodialysis: The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) Trial. Clin J Am Soc Nephrol. 2015 May 7;10(5):791-9. doi: 10.2215/CJN.07730814. Epub 2015 Feb 20. PubMed 25710802 ↗
  • Wheeler DC, London GM, Parfrey PS, Block GA, Correa-Rotter R, Dehmel B, Drueke TB, Floege J, Kubo Y, Mahaffey KW, Goodman WG, Moe SM, Trotman ML, Abdalla S, Chertow GM, Herzog CA; EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) Trial Investigators. Effects of cinacalcet on atherosclerotic and nonatherosclerotic cardiovascular events in patients receiving hemodialysis: the EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) trial. J Am Heart Assoc. 2014 Nov 17;3(6):e001363. doi: 10.1161/JAHA.114.001363. Erratum In: J Am Heart Assoc. 2015 Jan;4(1):e000570. PubMed 25404192 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00345839
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Jun 29, 2006
Start date
Aug 22, 2006
Primary completion
Apr 10, 2012
Completion
Apr 10, 2012
Results posted
Jan 22, 2014
Last update
Nov 7, 2022

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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