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

NCT01681303 | Completed Phase 4

• 2 other identifiers: IWW-000498-794A3
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• renal function change

  1 year

Secondary Outcomes (1)

• anemia

  1 year

Other Outcomes (1)

• lipid profile and uric acid

  1 year

Study Arms (2)

AST-120 group

EXPERIMENTAL

Administration of AST-120

Drug: AST-120

2

NO INTERVENTION

Interventions

AST-120 DRUG

AST-120 group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Nephrology, Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

AST 120

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• I-Wen Wu, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 7, 2012
• Study Start: January 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 6, 2013

Record last verified: 2013-08

Locations

TW (1)