A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2) - Full Text View

Sponsors and Collaborators:	Mitsubishi Tanabe Pharma Corporation Kureha Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00501046

Purpose

1) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function and quality of life.

Condition	Intervention	Phase
Chronic Kidney Disease	Drug: Placebo Drug: AST-120	Phase III

MedlinePlus related topics: Kidney Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AST-120 for Prevention of Chronic Kidney Disease Progression in Patients With Moderate to Severe Chronic Kidney Disease Including Assessment of Quality of Life

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

The development of a component of a triple composite endpoint (initiation of dialysis, kidney transplant, or doubling of sCr) [ Time Frame: approximately 42 months (at least 18 months for enrollment and 24 months for treatment) ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: approximately 42 months (at least 18 months for enrollment and 24 months for treatment) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The development of a component of a quadruple composite endpoint (initiation of dialysis, kidney transplant, doubling of sCr, or death), other measures of renal function and (QOL: exploratory) [ Time Frame: approximately 42 months (at least 18 months for enrollment and 24 months for treatment) ] [ Designated as safety issue: No ]
Vitamins and folate levels [ Time Frame: approximately 42 months (at least 18 months for enrollment and 24 months for treatment) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	July 2007
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo 9g /day (3 times a day)
2: Experimental	Drug: AST-120 9g /day (3 times a day)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18 years or older
Moderate to severe CKD, not anticipated to require dialysis or renal transplant within the next 6 months
Patient survival expected to be no less than one year
Serum creatinine in men >= 2.0 mg/dL (>= 177 µmol/L) and <= 5.0 mg/dL (<= 442 µmol/L), and in women >= 1.5 mg/dL (>= 133 µmol/L) and <= 5.0 mg/dL (<= 442 µmol/L) at Screening
Urinary total protein to urinary total creatinine ratio must be >= 0.5 on a spot void obtained at Screening
Blood pressure <= 160/90 mmHg at both Screening and Baseline visits. In addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to Screening, with no more than 1 blood pressure reading > 160/90 mmHg
In patients being treated for hypertension, they should be on a stable anti-hypertensive regimen

Exclusion Criteria:

Obstructive or reversible cause of kidney disease
Nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of > 6.0 as measured on a spot void
Adult polycystic kidney disease
History of previous kidney transplant
History of recent (within the past 6 months) accelerated or malignant hypertension
Uncontrolled arrhythmia or severe cardiac disease within the past 6 months
History of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe GI dysmotility, not attributable to the use of a phosphate binder
Received any investigational agent or participated in a clinical study within the previous 3 months
Presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501046

Contacts

Contact: Infomation at Mitsubishi Pharma America, Inc

EPPIC_2@m-pharma.com

Show 82 Study Locations

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Kureha Corporation

Investigators

Principal Investigator:

Professor

Information at Mitsubishi Pharma America, Inc.

More Information

Responsible Party:	Mitsubishi Tanabe Pharma Coorporation ( Study Project Manager )
Study ID Numbers:	KRM-307
Study First Received:	July 11, 2007
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00501046
Health Authority:	United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Spain: Spanish Agency of Medicines; Ukraine: Ministry of Health; Argentina: Ministry of Justice, Personal Data Protection Department; Czech Republic: State Institute for Drug Control; Mexico: National Institute of Public Health, Health Secretariat; Poland: Ministry of Health

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Kidney Diseases

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Disease Progression

Kidney Failure, Chronic
Quality of Life
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 14, 2009