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

This study has been completed.
Sponsor:
Collaborator:
Kureha Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00500682
First received: July 11, 2007
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  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 3

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:

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 ]

Enrollment: 1020
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: October 1, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation
Italy: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013