CKDkb: a knowledge base and platform for drug development against non-alcoholic fatty liver disease

Clinical Trial Details

Trial ID:	L0602
Source ID:	NCT00598273
Associated Drug:	Peginesatide
Title:	Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
Acronym:	PEARL 1
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT00598273/results
Conditions:	Chronic Renal Failure\|Chronic Kidney Disease\|Anemia
Interventions:	DRUG: peginesatide\|DRUG: peginesatide\|DRUG: Darbepoetin alfa
Outcome Measures:	Primary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period, The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 25 through 36., Baseline and Weeks 25-36 \| Secondary: Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods, Weeks 0 to 36\|Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods., A hemoglobin response is defined as hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks., Weeks 0 to 36
Sponsor/Collaborators:	Sponsor: Affymax \| Collaborators: Takeda
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	490
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: NONE\|Primary Purpose: TREATMENT
Start Date:	2007-10
Completion Date:	2010-02
Results First Posted:	2012-07-30
Last Update Posted:	2013-02-12
Locations:	Research Facility, Montgomery, Alabama, 36106, United States\|Research Facility, Tempe, Arizona, 85306, United States\|Research Facility, Hot Springs, Arkansas, 71901, United States\|Research Facility, Bakersfield, California, 93309, United States\|Research Facility, Chula Vista, California, 91910, United States\|Research Facility, Glendale, California, 91204, United States\|Research Facility, Huntington Beach, California, 92646, United States\|Research Facility, Los Angeles, California, 90095, United States\|Research Facility, Orange, California, 92868, United States\|Research Facility, Paramount, California, 90723, United States\|Research Facility, Pasadena, California, 91106, United States\|Research Facility, Riverside, California, 92505, United States\|Research Facility, San Dimas, California, 91773, United States\|Research Facility, Stanford, California, 94305-6203, United States\|Research Facility, Whittier, California, 90603, United States\|Research Facility, Whittier, California, 90606, United States\|Research Facility, Yuba City, California, 95991, United States\|Research Facility, Thornton, Colorado, 80031, United States\|Research Facility, Washington, District of Columbia, 20037, United States\|Research Facility, Holly Hill, Florida, 32117, United States\|Research Facility, Hudson, Florida, 34667, United States\|Research Facility, Miami, Florida, 33173, United States\|Research Facility, Ocala, Florida, 34471, United States\|Research Facility, Orlando, Florida, 32804, United States\|Research Facility, Tampa, Florida, 33614, United States\|Research Facility, Augusta, Georgia, 30901, United States\|Research Facility, Honolulu, Hawaii, 96817, United States\|Research Facility, Chicago, Illinois, 60616, United States\|Research Facility, Evergreen Park, Illinois, 60805, United States\|Research Facility, Hines, Illinois, 60141, United States\|Research Facility, Evansville, Indiana, 47714, United States\|Research Facility, Lafayette, Indiana, 47904, United States\|Research Facility, Wichita, Kansas, 67214, United States\|Research Facility, Shreveport, Louisiana, 71101, United States\|Research Facility, Bethesda, Maryland, 20814, United States\|Research Facility, Fall River, Massachusetts, 02720, United States\|Research Facility, Worcester, Massachusetts, 01608, United States\|Research Facility, Midland, Michigan, 48640, United States\|Research Facility, Columbus, Mississippi, 39705, United States\|Research Facility, Kansas City, Missouri, 64128, United States\|Research Facility, Northfield, New Jersey, 08225, United States\|Research Facility, Toms River, New Jersey, 08755, United States\|Research Facility, Binghamton, New York, 13903, United States\|Research Facility, Great Neck, New York, 11021, United States\|Research Facility, Mineola, New York, 11501, United States\|Research Facility, Charlotte, North Carolina, 28208, United States\|Research Facility, Oklahoma City, Oklahoma, 73116, United States\|Research Facility, Bend, Oregon, 97701, United States\|Research Facility, Portland, Oregon, 97210, United States\|Research Facility, Allentown, Pennsylvania, 18103, United States\|Research Facility, Erie, Pennsylvania, 16507, United States\|Research Facility, Johnstown, Pennsylvania, 15905, United States\|Research Facility, Providence, Rhode Island, 02904, United States\|Research Facility, Orangeburg, South Carolina, 29118, United States\|Research Facility, Rock Hill, South Carolina, 29732, United States\|Research Facility, Clarksville, Tennessee, 37043, United States\|Research Facility, Knoxville, Tennessee, 37923, United States\|Research Facility, Nashville, Tennessee, 37205, United States\|Research Facility, Austin, Texas, 78705, United States\|Research Facility, Corpus Christi, Texas, 78404, United States\|Research Facility, Corsicana, Texas, 75110, United States\|Research Facility, Edinburg, Texas, 78539, United States\|Research Facility, Houston, Texas, 77030, United States\|Research Facility, Houston, Texas, 77099, United States\|Research Facility, San Antonio, Texas, 78215, United States\|Research Facility, San Antonio, Texas, 78229, United States\|Research Facility, Salem, Virginia, 24153, United States\|Research Facility, Bluefield, West Virginia, 24701, United States\|Research Facility, Caguas, 00725, Puerto Rico\|Research Facility, Ponce, 00716, Puerto Rico\|Research Facility, San Juan, 00909, Puerto Rico\|Research Facility, San Juan, 00918, Puerto Rico
URL:	https://clinicaltrials.gov/show/NCT00598273

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Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress

Clinical Trial Details

Summary

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Associated Data

Associated NAFLD Drugs (0)