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

NCT00680017 | Completed Phase 3 Results

• 1 other identifier: M10-313
• Study Type: interventional
• Target: 280
• Locations: 2 countries
• Sites: 114

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.

Conditions

Dyslipidemia; Kidney Disease

Keywords

Dyslipidemia; Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Median Percent Change in Triglycerides From Baseline to Week 8.

  Triglycerides were measured in milligrams/deciliter.

  Baseline to 8 weeks

Secondary Outcomes (1)

• Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8.

  Baseline to 8 weeks

Study Arms (2)

ABT-335 plus rosuvastatin

EXPERIMENTAL

ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks

Drug: ABT-335 plus rosuvastatin

Rosuvastatin

ACTIVE COMPARATOR

Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks

Drug: Rosuvastatin

Interventions

ABT-335 plus rosuvastatin DRUG

ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks

Also known as: fenofibric acid and rosuvastatin

ABT-335 plus rosuvastatin

Rosuvastatin DRUG

Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks

Also known as: rosuvastatin, Crestor

Rosuvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (114)

Site Reference ID/Investigator# 22521

Birmingham, Alabama, 35242, United States

Location

Site Reference ID/Investigator# 22478

Huntsville, Alabama, 35801, United States

Location

Site Reference ID/Investigator# 8365

Madison, Alabama, 35758, United States

Location

Site Reference ID/Investigator# 8416

Montgomery, Alabama, 36106-1111, United States

Location

Site Reference ID/Investigator# 7869

Chula Vista, California, 91910, United States

Location

Site Reference ID/Investigator# 8435

Fountain Valley, California, 92708, United States

Location

Site Reference ID/Investigator# 22487

Lincoln, California, 95648, United States

Location

Site Reference ID/Investigator# 22426

Long Beach, California, 90806, United States

Location

Site Reference ID/Investigator# 8096

Los Angeles, California, 90048, United States

Location

Site Reference ID/Investigator# 22962

Norwalk, California, 90650, United States

Location

Site Reference ID/Investigator# 8311

Riverside, California, 92505, United States

Location

Site Reference ID/Investigator# 22816

Sacramento, California, 95825, United States

Location

Site Reference ID/Investigator# 8510

Simi Valley, California, 93065, United States

Location

Site Reference ID/Investigator# 22821

West Hills, California, 91307, United States

Location

Site Reference ID/Investigator# 7958

Arvada, Colorado, 80002, United States

Location

Site Reference ID/Investigator# 15881

Denver, Colorado, 80230, United States

Location

Site Reference ID/Investigator# 8399

Westminster, Colorado, 80031, United States

Location

Site Reference ID/Investigator# 23224

Boynton Beach, Florida, 33472, United States

Location

Site Reference ID/Investigator# 22474

Clearwater, Florida, 33756, United States

Location

Site Reference ID/Investigator# 21803

Coral Springs, Florida, 33065, United States

Location

Site Reference ID/Investigator# 22811

Daytona Beach, Florida, 32117, United States

Location

Site Reference ID/Investigator# 27103

Hollywood, Florida, 33021, United States

Location

Site Reference ID/Investigator# 8398

Hudson, Florida, 34667, United States

Location

Site Reference ID/Investigator# 26723

Kissimmee, Florida, 34741, United States

Location

Site Reference ID/Investigator# 37676

Kissimmee, Florida, 34759, United States

Location

Site Reference ID/Investigator# 8231

Lauderdale Lakes, Florida, 33313, United States

Location

Site Reference ID/Investigator# 22486

Longwood, Florida, 32779, United States

Location

Site Reference ID/Investigator# 22520

New Port Richey, Florida, 34652, United States

Location

Site Reference ID/Investigator# 8226

Orlando, Florida, 32804, United States

Location

Site Reference ID/Investigator# 22477

Ormond Beach, Florida, 32174, United States

Location

Site Reference ID/Investigator# 8386

Pembroke Pines, Florida, 33028, United States

Location

Site Reference ID/Investigator# 22518

Plant City, Florida, 33563, United States

Location

Site Reference ID/Investigator# 12882

Port Charlotte, Florida, 33952, United States

Location

Site Reference ID/Investigator# 37675

Saint Cloud, Florida, 34769, United States

Location

Site Reference ID/Investigator# 8410

West Palm Beach, Florida, 33401, United States

Location

Site Reference ID/Investigator# 21802

Winter Haven, Florida, 33880, United States

Location

Site Reference ID/Investigator# 8136

Atlanta, Georgia, 30331, United States

Location

Site Reference ID/Investigator# 23503

Dunwoody, Georgia, 30338, United States

Location

Site Reference ID/Investigator# 7948

Macon, Georgia, 31217, United States

Location

Site Reference ID/Investigator# 22819

Roswell, Georgia, 30076, United States

Location

Site Reference ID/Investigator# 22813

Suwanee, Georgia, 30024, United States

Location

Site Reference ID/Investigator# 27682

Chicago, Illinois, 60616, United States

Location

Site Reference ID/Investigator# 8227

Peoria, Illinois, 61603, United States

Location

Site Reference ID/Investigator# 13922

Mishawaka, Indiana, 46545-3519, United States

Location

Site Reference ID/Investigator# 8094

Council Bluffs, Iowa, 51501, United States

Location

Site Reference ID/Investigator# 22430

Iowa City, Iowa, 52242, United States

Location

Site Reference ID/Investigator# 8093

Paducah, Kentucky, 42003, United States

Location

Site Reference ID/Investigator# 38405

Baton Rouge, Louisiana, 70809, United States

Location

Site Reference ID/Investigator# 8903

Shreveport, Louisiana, 71101, United States

Location

Site Reference ID/Investigator# 21805

Auburn, Maine, 04210, United States

Location

Site Reference ID/Investigator# 8092

Rockville, Maryland, 20852, United States

Location

Site Reference ID/Investigator# 8225

Fall River, Massachusetts, 02720, United States

Location

Site Reference ID/Investigator# 8407

Springfield, Massachusetts, 01107, United States

Location

Site Reference ID/Investigator# 8415

Royal Oak, Michigan, 48073, United States

Location

Site Reference ID/Investigator# 22222

Brooklyn Center, Minnesota, 55430, United States

Location

Site Reference ID/Investigator# 8408

Olive Branch, Mississippi, 38654, United States

Location

Site Reference ID/Investigator# 22703

Berlin, New Jersey, 08009, United States

Location

Site Reference ID/Investigator# 22707

Elizabeth, New Jersey, 07202, United States

Location

Site Reference ID/Investigator# 22702

Hillsborough, New Jersey, 08844, United States

Location

Site Reference ID/Investigator# 8387

Flushing, New York, 11355, United States

Location

Site Reference ID/Investigator# 8177

Great Neck, New York, 11021, United States

Location

Site Reference ID/Investigator# 8146

Lake Success, New York, 11042, United States

Location

Site Reference ID/Investigator# 22427

Williamsville, New York, 14221, United States

Location

Site Reference ID/Investigator# 22481

Charlotte, North Carolina, 28262, United States

Location

Site Reference ID/Investigator# 22708

Charlotte, North Carolina, 28277, United States

Location

Site Reference ID/Investigator# 8434

Morehead City, North Carolina, 28557, United States

Location

Site Reference ID/Investigator# 8417

Cincinnati, Ohio, 45267-0585, United States

Location

Site Reference ID/Investigator# 8147

Columbus, Ohio, 43215, United States

Location

Site Reference ID/Investigator# 22488

Mason, Ohio, 45040, United States

Location

Site Reference ID/Investigator# 22479

Oklahoma City, Oklahoma, 73103, United States

Location

Site Reference ID/Investigator# 23225

Oklahoma City, Oklahoma, 73112, United States

Location

Site Reference ID/Investigator# 22482

Tulsa, Oklahoma, 74136, United States

Location

Site Reference ID/Investigator# 8345

Bend, Oregon, 97701, United States

Location

Site Reference ID/Investigator# 22704

Medford, Oregon, 97504, United States

Location

Site Reference ID/Investigator# 8400

Portland, Oregon, 97210, United States

Location

Site Reference ID/Investigator# 8411

Bethlehem, Pennsylvania, 18017, United States

Location

Site Reference ID/Investigator# 8405

Carlisle, Pennsylvania, 17015, United States

Location

Site Reference ID/Investigator# 22387

Duncansville, Pennsylvania, 16635, United States

Location

Site Reference ID/Investigator# 22815

Jersey Shore, Pennsylvania, 17740, United States

Location

Site Reference ID/Investigator# 12881

Johnstown, Pennsylvania, 15905, United States

Location

Site Reference ID/Investigator# 22706

Perkasie, Pennsylvania, 18944, United States

Location

Site Reference ID/Investigator# 8095

Philadelphia, Pennsylvania, 19107, United States

Location

Site Reference ID/Investigator# 22705

Tipton, Pennsylvania, 16684, United States

Location

Site Reference ID/Investigator# 22817

Warminster, Pennsylvania, 18974, United States

Location

Site Reference ID/Investigator# 8098

Providence, Rhode Island, 02904, United States

Location

Site Reference ID/Investigator# 22823

Charleston, South Carolina, 29412, United States

Location

Site Reference ID/Investigator# 8364

Columbia, South Carolina, 29206, United States

Location

Site Reference ID/Investigator# 22429

Greenville, South Carolina, 29605, United States

Location

Site Reference ID/Investigator# 22428

Mt. Pleasant, South Carolina, 29464, United States

Location

Site Reference ID/Investigator# 25302

Summerville, South Carolina, 29485, United States

Location

Site Reference ID/Investigator# 22812

Dallas, Texas, 75251, United States

Location

Site Reference ID/Investigator# 8536

Edinburg, Texas, 78539, United States

Location

Site Reference ID/Investigator# 22810

Fort Worth, Texas, 76104, United States

Location

Site Reference ID/Investigator# 24742

Houston, Texas, 77005, United States

Location

Site Reference ID/Investigator# 26722

Houston, Texas, 77024, United States

Location

Site Reference ID/Investigator# 8406

Houston, Texas, 77099, United States

Location

Site Reference ID/Investigator# 8232

Lubbock, Texas, 79410, United States

Location

Site Reference ID/Investigator# 22480

San Antonio, Texas, 78224, United States

Location

Site Reference ID/Investigator# 8397

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 21804

Ogden, Utah, 84403, United States

Location

Site Reference ID/Investigator# 22423

Salt Lake City, Utah, 84124, United States

Location

Site Reference ID/Investigator# 8413

Gig Harbor, Washington, 98335, United States

Location

Site Reference ID/Investigator# 24402

Carolina, 00983, Puerto Rico

Location

Site Reference ID/Investigator# 22545

Humacao, 00791, Puerto Rico

Location

Site Reference ID/Investigator# 8301

Manatí, 00674, Puerto Rico

Location

Site Reference ID/Investigator# 8299

Ponce, 00717-0634, Puerto Rico

Location

Site Reference ID/Investigator# 8418

Ponce, 00717-1322, Puerto Rico

Location

Site Reference ID/Investigator# 8419

Ponce, 00717-2075, Puerto Rico

Location

Site Reference ID/Investigator# 8421

San Juan, 00907, Puerto Rico

Location

Site Reference ID/Investigator# 8300

San Juan, 00909, Puerto Rico

Location

Site Reference ID/Investigator# 8422

San Juan, 00918, Puerto Rico

Location

Site Reference ID/Investigator# 8423

San Juan, 00936-5067, Puerto Rico

Location

Site Reference ID/Investigator# 8420

Toa Baja, 00949, Puerto Rico

Location

Site Reference ID/Investigator# 8298

Yabucoa, 00767, Puerto Rico

Location

Related Publications (2)

• Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

  PMID: 38018702 DERIVED

• 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.

  PMID: 23891363 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Kidney Diseases

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid; Rosuvastatin Calcium; fenofibric acid

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

+44 1509 645 895

Study Officials

• Torbjörn Lundström, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 19, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 3, 2012
• Results First Posted: July 16, 2012

Record last verified: 2012-09

Locations

PR (12); US (102)