A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease (EPPIC-1) - Full Text View

Sponsor:	Mitsubishi Tanabe Pharma Corporation
Collaborator:	Kureha Corporation
Information provided by (Responsible Party):	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00500682

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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure Kidney Transplantation

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: approximately 42 months ] [ 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 [ Time Frame: approximately 42 months ] [ Designated as safety issue: No ]
Vitamins and folate levels [ Time Frame: approximately 42 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	980
Study Start Date:	July 2007
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo 9g /day (3 times a day)
Experimental: AST-120	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 at Screening
Blood pressure <= 160/90 mmHg at both Screening and Baseline. 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: NCT00500682

Show 105 Study Locations

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Kureha Corporation

Investigators

Principal Investigator:

Professor

Information at Mitsubishi Tanabe Pharma Development America, Inc.

More Information

No publications provided

Responsible Party:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00500682 History of Changes
Other Study ID Numbers:	KRM-306
Study First Received:	July 11, 2007
Last Updated:	November 3, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Russia: Ministry of Health and Social Development of the Russian Federation; Italy: Ministry of Health; France: Afssaps - French Health Products Safety Agency; Ukraine: Ministry of Health; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Czech Republic: State Institute for Drug Control; Mexico: National Institute of Public Health, Health Secretariat; Poland: Ministry of Health; Brazil: National Health Surveillance Agency

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Kidney Diseases

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on February 09, 2012