Effect of An Oral Absorbent AST-120 in Late-stage Chronic Kidney Disease (CKD) Patients.

NCT ID: NCT01681303

Last Updated: 2013-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-12-31

Brief Summary

Recent research work has directed especial attention toward a distinct group of uremic retension molecules, called "protein-bound uremic toxins". The prototypes of this group of uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production of free radical and impair antioxidant system and exerts direct toxicity on different cells and organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of these protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis of kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic patients. In hemodialysis, high serum p-cresol level is associated with higher cardiovascular mortality.

AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It has superior adsorption ability for certain small-molecular weight organic compounds known to accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it was reported that AST-120 suppressed the increase in serum creatinine levels, prevented proteinuria, improved uremic symptoms, and, consequently, led to the postponement of dialysis therapy.

Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the morbidity- mortality of CKD patients.

The principal aim of this prospective cohort study is to investigate the effectiveness of AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of this relationship can help to establish new therapeutic strategy in the treatment of late-stage CKD patients.

Conditions

Chronic Kidney Disease; AST-120

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AST-120 group

Administration of AST-120

Group Type: EXPERIMENTAL

AST-120

Intervention Type: DRUG

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AST-120

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adults aged > 18 year-old or < 85 year-old
• eGFR or CCR < 60 ml/min
• hemoglobin < 10 g/dL, ESA-naïve, had adequate iron storage (serum ferritin > 200 ng/dL and transferrin saturation > 20%)
• no spontaneous renal improvement or progression in past 3 months.

Exclusion Criteria

• renal transplant recipients, liver cirrhosis, bone marrow disorder
• blood pressure > 170/80 mmHg in 3 occasions
• recent cardiovascular disease (Coronary artery disease, myocardial ischemia, cerebrovascular disease or peripheral artery disease) or gastrointestinal bleeding in past 3 months
• acute tubular necrosis in the past 3 months
• unwilling to participate in the trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

iwenwu

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

I-Wen Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Department of Nephrology, Chang Gung Memorial Hospital

Keelung, , Taiwan

Countries

Taiwan

Other Identifiers

98-794A3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IWW-0004

Identifier Type: -

Identifier Source: org_study_id