A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury

Phase 3

• Conditions: Acute Kidney Injury
• Interventions: Drug: AST-120and pentoxyphylline (PTX); Drug: pentoxyphylline (PTX)

• Registration Number: NCT02687841
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Hospital acquired acute kidney injury is an important negative outcome predictor for hospitalized patients. Uremic toxins accumulated after a given renal insult. Some of these uremic toxins are protein bound and may accumulated after renal impairment, owing to both impaired filtration, and inflammation. Recent animal studies have reported that accumulation of uremic toxins, namely indoxyl sulfate and p-cresol, would down regulate endothelial progenitor cells and in turn affect renal recovery. Elimination of these protein bound uremic toxins with an activated charcoal would help restore endothelial function. We will conduct a double blinded randomized placebo controlled trial, which aims to determine that if oral activated charcoal will retard progression of AKI. Also, a panel of markers for endothelial function will also be determined.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-26
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-17
• Last Update Submitted: 2016-02-17
• Study First Posted: 2016-02-22
• Last Update Posted: 2016-02-22
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AST-120 and PTX	AST-120and pentoxyphylline (PTX)	AST-120 2g 4 times a day for 5 days then AST-120 2g 3 times a day for 5 days Pentapentoxifylline 400mg QD for 10 days
PTX	pentoxyphylline (PTX)	Pentapentoxifylline 400mg QD for 10 days

Primary Outcome Measures

Name	Time	Method
Total recovery of kidney function, which is defined as less than 1.5 times pre-morbid creatinine levels on the 10th day of intervention.	10 days

Secondary Outcome Measures

Name	Time	Method
Total recovery of serum creatinine on Day 5	5 days	defined with less than 1.5 times elevation of pre-morbid plasma creatinine level.
Needing renal replacement therapy on day 10.	10 days
Degree of serum creatinine elevation	10 days	as calculated with ratios between highest serum creatinine and pre-morbid creatinine during study period
The degree of Indoxyl sulfate change on Day 10 (%)	10 days
The degree of Indoxyl sulfate change on Day 5 (%)	5 days
The degree of p-cresol change on Day 10 (%)	10 days
The degree of p-cresol change on Day 5 (%)	5 days

Trial Locations

Locations (1)

National Taiwan University Hospital Yun-Lin Branch; 🇨🇳 Douliou, Taiwan