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

Acute Kidney Injury Clinical Trial

Official title:

A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury - A Open Label Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02687841
• Other study ID #: 201502003MIPB
• Status: Recruiting
• Phase: Phase 3
• First received: January 26, 2016
• Last updated: February 17, 2016
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: National Taiwan University Hospital
• Contact: Tao-Min Huang
• Phone: 0972655730
• Email: taominhuang[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 206
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 100 Years

Eligibility

This is a prospective randomized placebo controlled trial. All patients admitted to participating centers with newly diagnosed acute kidney injury (AKI) will be screened for eligibility. The diagnosis of AKI will be determined and staged according to the KIGO-AKI Guideline.11 The inclusion criteria include:

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• 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.
• pentoxyphylline (PTX)
pentoxyphylline 400mg QD PO x 10 days.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Yun-Lin Branch	Douliou

Sponsors (7)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Chang Gung Memorial Hospital, China Medical University Hospital, National Taiwan University Hospital Hsin-Chu Branch, National Taiwan University Hospital, Yun-Lin Branch, Taipei Medical University Hospital, Taoyuan General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Total recovery of serum creatinine on Day 5	defined with less than 1.5 times elevation of pre-morbid plasma creatinine level.	5 days	No
Secondary	Needing renal replacement therapy on day 10.		10 days	No
Secondary	Degree of serum creatinine elevation	as calculated with ratios between highest serum creatinine and pre-morbid creatinine during study period	10 days	No
Secondary	The degree of Indoxyl sulfate change on Day 10 (%)		10 days	No
Secondary	The degree of Indoxyl sulfate change on Day 5 (%)		5 days	No
Secondary	The degree of p-cresol change on Day 10 (%)		10 days	No
Secondary	The degree of p-cresol change on Day 5 (%)		5 days	No