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

NCT ID: NCT02687841

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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

Study Design

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

Study Groups

AST-120 and 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

Group Type: EXPERIMENTAL

AST-120and pentoxyphylline (PTX)

Intervention Type: 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.

PTX

Pentapentoxifylline 400mg QD for 10 days

Group Type: ACTIVE_COMPARATOR

pentoxyphylline (PTX)

Intervention Type: DRUG

pentoxyphylline 400mg QD PO x 10 days.

Interventions

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 pentoxyphylline 400mg QD PO x 10 days.

Intervention Type: DRUG

pentoxyphylline (PTX)

pentoxyphylline 400mg QD PO x 10 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 20 years old on the day of admission

2. 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:

1. Baseline estimated glomerular filtration rates (eGFR) less than 30ml/min/1.73m2 or greater than 90ml/min/1.73m2 according to MDRD equation.

2. Acute kidney injury diagnosed in the indexed admission (according to baseline creatinine)

3. Ileus or under fasting status

4. Previous gastrointestinal operation.

5. 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.

6. Patients had ever undergone any modality of renal replacement therapy (RRT)

7. Patients with major hemorrhage, as defined with requirement of blood transfusion during index admission.

8. Patients with a biopsy proved or clinically diagnosed liver cirrhosis, Child classification B or C.

9. Patients with a congestive heart failure of NYHA Class III or IV, or requirement of inotropic agents.

10. Patients with a chronic lung disease requiring non-invasive or invasive positive pressure ventilation.

11. Solid organ or hematological transplantation donors.

12. Patients who had been diagnosed as AKI in the index hospitalization, as defined with KDIGO 2012 criteria.

13. Patients with oliguric acute kidney injury, as defined with less than 500cc/day.

14. Evidence of obstructive acute kidney injury under kidney echosonography.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital, Yun-Lin Branch

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: collaborator

Taoyuan General Hospital

OTHER_GOV

Sponsor Role: collaborator

Taipei Medical University Hospital

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Hospital

KWAN-DUN WU MD. PhD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YU-SHENG WU

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Tao-Min Huang

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Yun-Lin Branch

Wei-Shun Yang

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital Hsin-Chu Branch

JUI-HSIANG LIN

Role: PRINCIPAL_INVESTIGATOR

Taoyuan General Hospital

Ya-Fei Yang

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Chan-Yu Lin

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Heng-Chih Pan

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Chih-Chin Kao

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Hospital

Locations

National Taiwan University Hospital Yun-Lin Branch

Douliu, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Tao-Min Huang

Role: CONTACT

taominhuang@gmail.com

0972655730

KWAN-DUN WU

Role: CONTACT

0972651011

Facility Contacts

Tao-Min Huang

Role: primary

taominhuang@gmail.com

0972655730

Other Identifiers

201502003MIPB

Identifier Type: -

Identifier Source: org_study_id