Clinical trial NCT00680017: 30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease
Official title: A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia
Kidney Disease
Keywords: Dyslipidemia
Kidney Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-19
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.


Eligibility criteria: Inclusion Criteria

* Dyslipidemic participants with Chronic Kidney Disease Stage 3
* For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit\[s\]):

  * Estimated glomerular filtration rate between 30 and 59 mL/min/1.73 m2 (Chronic Kidney Disease Stage 3) by simplified 4 variable Modification of Diet in Renal Disease formula (this includes a 10 percent variation in the upper limit of estimated glomerular filtration rate that was allowed for the enrollment of participants to account for variability in the creatinine assay).
  * Fasting lipid results following greater than or equal to 12-hour fasting period:
* Triglycerides level greater than or equal to 150 mg/dL,
* High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and
* Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL Exclusion Criteria
* Participants with certain chronic or unstable medical conditions.
* Participants with unstable dose of medications or receiving coumarin anticoagulants, systemic cyclosporine, or certain other medications.
* Pregnant or lactating women, or women intending to become pregnant.
* Participants with diabetes mellitus that is poorly controlled.
* Participants of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin).

Primary outcomes:
measure: Median Percent Change in Triglycerides From Baseline to Week 8.
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.
timeFrame: Baseline to 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 22521
state: Alabama
city: Huntsville
country: United States
facility: Site Reference ID/Investigator# 22478
state: Alabama
city: Madison
country: United States
facility: Site Reference ID/Investigator# 8365
state: Alabama
city: Montgomery
country: United States
facility: Site Reference ID/Investigator# 8416
state: Alabama
city: Chula Vista
country: United States
facility: Site Reference ID/Investigator# 7869
state: California
city: Fountain Valley
country: United States
facility: Site Reference ID/Investigator# 8435
state: California
city: Lincoln
country: United States
facility: Site Reference ID/Investigator# 22487
state: California
city: Long Beach
country: United States
facility: Site Reference ID/Investigator# 22426
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 8096
state: California
city: Norwalk
country: United States
facility: Site Reference ID/Investigator# 22962
state: California
city: Riverside
country: United States
facility: Site Reference ID/Investigator# 8311
state: California
city: Sacramento
country: United States
facility: Site Reference ID/Investigator# 22816
state: California
city: Simi Valley
country: United States
facility: Site Reference ID/Investigator# 8510
state: California
city: West Hills
country: United States
facility: Site Reference ID/Investigator# 22821
state: California
city: Arvada
country: United States
facility: Site Reference ID/Investigator# 7958
state: Colorado
city: Denver
country: United States
facility: Site Reference ID/Investigator# 15881
state: Colorado
city: Westminster
country: United States
facility: Site Reference ID/Investigator# 8399
state: Colorado
city: Boynton Beach
country: United States
facility: Site Reference ID/Investigator# 23224
state: Florida
city: Clearwater
country: United States
facility: Site Reference ID/Investigator# 22474
state: Florida
city: Coral Springs
country: United States
facility: Site Reference ID/Investigator# 21803
state: Florida
city: Daytona Beach
country: United States
facility: Site Reference ID/Investigator# 22811
state: Florida
city: Hollywood
country: United States
facility: Site Reference ID/Investigator# 27103
state: Florida
city: Hudson
country: United States
facility: Site Reference ID/Investigator# 8398
state: Florida
city: Kissimmee
country: United States
facility: Site Reference ID/Investigator# 26723
state: Florida
city: Kissimmee
country: United States
facility: Site Reference ID/Investigator# 37676
state: Florida
city: Lauderdale Lakes
country: United States
facility: Site Reference ID/Investigator# 8231
state: Florida
city: Longwood
country: United States
facility: Site Reference ID/Investigator# 22486
state: Florida
city: New Port Richey
country: United States
facility: Site Reference ID/Investigator# 22520
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 8226
state: Florida
city: Ormond Beach
country: United States
facility: Site Reference ID/Investigator# 22477
state: Florida
city: Pembroke Pines
country: United States
facility: Site Reference ID/Investigator# 8386
state: Florida
city: Plant City
country: United States
facility: Site Reference ID/Investigator# 22518
state: Florida
city: Port Charlotte
country: United States
facility: Site Reference ID/Investigator# 12882
state: Florida
city: St. Cloud
country: United States
facility: Site Reference ID/Investigator# 37675
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 8410
state: Florida
city: Winter Haven
country: United States
facility: Site Reference ID/Investigator# 21802
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 8136
state: Georgia
city: Dunwoody
country: United States
facility: Site Reference ID/Investigator# 23503
state: Georgia
city: Macon
country: United States
facility: Site Reference ID/Investigator# 7948
state: Georgia
city: Roswell
country: United States
facility: Site Reference ID/Investigator# 22819
state: Georgia
city: Suwanee
country: United States
facility: Site Reference ID/Investigator# 22813
state: Georgia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 27682
state: Illinois
city: Peoria
country: United States
facility: Site Reference ID/Investigator# 8227
state: Illinois
city: Mishawaka
country: United States
facility: Site Reference ID/Investigator# 13922
state: Indiana
city: Council Bluffs
country: United States
facility: Site Reference ID/Investigator# 8094
state: Iowa
city: Iowa City
country: United States
facility: Site Reference ID/Investigator# 22430
state: Iowa
city: Paducah
country: United States
facility: Site Reference ID/Investigator# 8093
state: Kentucky
city: Baton Rouge
country: United States
facility: Site Reference ID/Investigator# 38405
state: Louisiana
city: Shreveport
country: United States
facility: Site Reference ID/Investigator# 8903
state: Louisiana
city: Auburn
country: United States
facility: Site Reference ID/Investigator# 21805
state: Maine
city: Rockville
country: United States
facility: Site Reference ID/Investigator# 8092
state: Maryland
city: Fall River
country: United States
facility: Site Reference ID/Investigator# 8225
state: Massachusetts
city: Springfield
country: United States
facility: Site Reference ID/Investigator# 8407
state: Massachusetts
city: Royal Oak
country: United States
facility: Site Reference ID/Investigator# 8415
state: Michigan
city: Brooklyn Center
country: United States
facility: Site Reference ID/Investigator# 22222
state: Minnesota
city: Olive Branch
country: United States
facility: Site Reference ID/Investigator# 8408
state: Mississippi
city: Berlin
country: United States
facility: Site Reference ID/Investigator# 22703
state: New Jersey
city: Elizabeth
country: United States
facility: Site Reference ID/Investigator# 22707
state: New Jersey
city: Hillsborough
country: United States
facility: Site Reference ID/Investigator# 22702
state: New Jersey
city: Flushing
country: United States
facility: Site Reference ID/Investigator# 8387
state: New York
city: Great Neck
country: United States
facility: Site Reference ID/Investigator# 8177
state: New York
city: Lake Success
country: United States
facility: Site Reference ID/Investigator# 8146
state: New York
city: Williamsville
country: United States
facility: Site Reference ID/Investigator# 22427
state: New York
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 22481
state: North Carolina
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 22708
state: North Carolina
city: Morehead City
country: United States
facility: Site Reference ID/Investigator# 8434
state: North Carolina
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 8417
state: Ohio
city: Columbus
country: United States
facility: Site Reference ID/Investigator# 8147
state: Ohio
city: Mason
country: United States
facility: Site Reference ID/Investigator# 22488
state: Ohio
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 22479
state: Oklahoma
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 23225
state: Oklahoma
city: Tulsa
country: United States
facility: Site Reference ID/Investigator# 22482
state: Oklahoma
city: Bend
country: United States
facility: Site Reference ID/Investigator# 8345
state: Oregon
city: Medford
country: United States
facility: Site Reference ID/Investigator# 22704
state: Oregon
city: Portland
country: United States
facility: Site Reference ID/Investigator# 8400
state: Oregon
city: Bethlehem
country: United States
facility: Site Reference ID/Investigator# 8411
state: Pennsylvania
city: Carlisle
country: United States
facility: Site Reference ID/Investigator# 8405
state: Pennsylvania
city: Duncansville
country: United States
facility: Site Reference ID/Investigator# 22387
state: Pennsylvania
city: Jersey Shore
country: United States
facility: Site Reference ID/Investigator# 22815
state: Pennsylvania
city: Johnstown
country: United States
facility: Site Reference ID/Investigator# 12881
state: Pennsylvania
city: Perkasie
country: United States
facility: Site Reference ID/Investigator# 22706
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 8095
state: Pennsylvania
city: Tipton
country: United States
facility: Site Reference ID/Investigator# 22705
state: Pennsylvania
city: Warminster
country: United States
facility: Site Reference ID/Investigator# 22817
state: Pennsylvania
city: Providence
country: United States
facility: Site Reference ID/Investigator# 8098
state: Rhode Island
city: Charleston
country: United States
facility: Site Reference ID/Investigator# 22823
state: South Carolina
city: Columbia
country: United States
facility: Site Reference ID/Investigator# 8364
state: South Carolina
city: Greenville
country: United States
facility: Site Reference ID/Investigator# 22429
state: South Carolina
city: Mount Pleasant
country: United States
facility: Site Reference ID/Investigator# 22428
state: South Carolina
city: Summerville
country: United States
facility: Site Reference ID/Investigator# 25302
state: South Carolina
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 22812
state: Texas
city: Edinburg
country: United States
facility: Site Reference ID/Investigator# 8536
state: Texas
city: Fort Worth
country: United States
facility: Site Reference ID/Investigator# 22810
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 24742
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 26722
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 8406
state: Texas
city: Lubbock
country: United States
facility: Site Reference ID/Investigator# 8232
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 22480
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 8397
state: Texas
city: Ogden
country: United States
facility: Site Reference ID/Investigator# 21804
state: Utah
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 22423
state: Utah
city: Gig Harbor
country: United States
facility: Site Reference ID/Investigator# 8413
state: Washington
city: Carolina
country: Puerto Rico
facility: Site Reference ID/Investigator# 24402
city: Humacao
country: Puerto Rico
facility: Site Reference ID/Investigator# 22545
city: Manati
country: Puerto Rico
facility: Site Reference ID/Investigator# 8301
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 8299
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 8418
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 8419
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 8421
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 8300
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 8422
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 8423
city: Toa Baja
country: Puerto Rico
facility: Site Reference ID/Investigator# 8420
city: Yabucoa
country: Puerto Rico
facility: Site Reference ID/Investigator# 8298
Study officials:
affiliation: AstraZeneca
name: Torbjörn Lundström, MD
role: STUDY_DIRECTOR
References:
citation: Weinstein DL, Williams LA, Carlson DM, Kelly MT, Burns KM, Setze CM, Lele A, Stolzenbach JC. A randomized, double-blind study of fenofibric acid plus rosuvastatin compared with rosuvastatin alone in stage 3 chronic kidney disease. Clin Ther. 2013 Aug;35(8):1186-98. doi: 10.1016/j.clinthera.2013.06.013. Epub 2013 Jul 26.