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

NCT02687841 | Unknown Phase 3 DMC

• 1 other identifier: 201502003MIPB
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Keywords

acute kidney injury; indoxylsulfate; p-cresol; AST-120

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Total recovery of serum creatinine on Day 5

  5 days

• Needing renal replacement therapy on day 10.

  10 days

• Degree of serum creatinine elevation

  10 days

• The degree of Indoxyl sulfate change on Day 10 (%)

  10 days

• The degree of Indoxyl sulfate change on Day 5 (%)

  5 days

Study Arms (2)

AST-120 and PTX

EXPERIMENTAL

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

Drug: AST-120and pentoxyphylline (PTX)

PTX

ACTIVE COMPARATOR

Pentapentoxifylline 400mg QD for 10 days

Drug: pentoxyphylline (PTX)

Interventions

AST-120and pentoxyphylline (PTX) DRUG

AST-120 2g 4 times a day for 5 days then AST-120 2g 3 times a day for 5 days pentoxyphylline 400mg QD PO x 10 days.

AST-120 and PTX

pentoxyphylline (PTX) DRUG

pentoxyphylline 400mg QD PO x 10 days.

PTX

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years old on the day of admission
• AKI develops during admission, as defined with KDIGO-AKI Guideline,11 namely, elevation of serum creatinine above 0.3mg/dL within two days, above 1.5times baseline.
• Patients with the following conditions will be excluded:
• Baseline estimated glomerular filtration rates (eGFR) less than 30ml/min/1.73m2 or greater than 90ml/min/1.73m2 according to MDRD equation.
• Acute kidney injury diagnosed in the indexed admission (according to baseline creatinine)
• Ileus or under fasting status
• Previous gastrointestinal operation.
• Chronic constipation, as defined with bowel movement less than three times a day. If usage of oral laxatives can achieve bowel movement of more than 3 times a day, this patient will not be excluded.
• Patients had ever undergone any modality of renal replacement therapy (RRT)
• Patients with major hemorrhage, as defined with requirement of blood transfusion during index admission.
• Patients with a biopsy proved or clinically diagnosed liver cirrhosis, Child classification B or C.
• Patients with a congestive heart failure of NYHA Class III or IV, or requirement of inotropic agents.
• Patients with a chronic lung disease requiring non-invasive or invasive positive pressure ventilation.
• Solid organ or hematological transplantation donors.
• Patients who had been diagnosed as AKI in the index hospitalization, as defined with KDIGO 2012 criteria.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital, Yun-Lin Branch: collaborator
• National Taiwan University Hospital Hsin-Chu Branch: collaborator
• China Medical University Hospital: collaborator
• Taoyuan General Hospital: collaborator
• Taipei Medical University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

National Taiwan University Hospital Yun-Lin Branch

Douliu, Taiwan, 640, Taiwan

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• YU-SHENG WU

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Tao-Min Huang

  National Taiwan University Hospital, Yun-Lin Branch

  PRINCIPAL INVESTIGATOR

• Wei-Shun Yang

  National Taiwan University Hospital Hsin-Chu Branch

  PRINCIPAL INVESTIGATOR

• JUI-HSIANG LIN

  Taoyuan General Hospital

  PRINCIPAL INVESTIGATOR

• Ya-Fei Yang

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

• Chan-Yu Lin

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Heng-Chih Pan

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Chih-Chin Kao

  Taipei Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao-Min Huang

CONTACT

0972655730; taominhuang@gmail.com

KWAN-DUN WU

CONTACT

0972651011

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KWAN-DUN WU MD. PhD.

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: February 22, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

TW (1)