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Trial record 69 of 440 for:    Taipei Medical University Hospital

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

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ClinicalTrials.gov Identifier: NCT02687841
Recruitment Status : Unknown
Verified February 2016 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Collaborators:
National Taiwan University Hospital, Yun-Lin Branch
National Taiwan University Hospital Hsin-Chu Branch
China Medical University Hospital
Taoyuan General Hospital
Taipei Medical University Hospital
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: AST-120and pentoxyphylline (PTX) Drug: pentoxyphylline (PTX) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury - A Open Label Randomized Control Trial
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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.

Active Comparator: PTX
Pentapentoxifylline 400mg QD for 10 days
Drug: pentoxyphylline (PTX)
pentoxyphylline 400mg QD PO x 10 days.




Primary Outcome Measures :
  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. [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Total recovery of serum creatinine on Day 5 [ Time Frame: 5 days ]
    defined with less than 1.5 times elevation of pre-morbid plasma creatinine level.

  2. Needing renal replacement therapy on day 10. [ Time Frame: 10 days ]
  3. Degree of serum creatinine elevation [ Time Frame: 10 days ]
    as calculated with ratios between highest serum creatinine and pre-morbid creatinine during study period

  4. The degree of Indoxyl sulfate change on Day 10 (%) [ Time Frame: 10 days ]
  5. The degree of Indoxyl sulfate change on Day 5 (%) [ Time Frame: 5 days ]
  6. The degree of p-cresol change on Day 10 (%) [ Time Frame: 10 days ]
  7. The degree of p-cresol change on Day 5 (%) [ Time Frame: 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687841


Contacts
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Contact: Tao-Min Huang 0972655730 taominhuang@gmail.com
Contact: KWAN-DUN WU 0972651011

Locations
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Taiwan
National Taiwan University Hospital Yun-Lin Branch Recruiting
Douliou, Taiwan, 640
Contact: Tao-Min Huang    0972655730    taominhuang@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
National Taiwan University Hospital, Yun-Lin Branch
National Taiwan University Hospital Hsin-Chu Branch
China Medical University Hospital
Taoyuan General Hospital
Taipei Medical University Hospital
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: 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

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Responsible Party: National Taiwan University Hospital, KWAN-DUN WU MD. PhD.
ClinicalTrials.gov Identifier: NCT02687841     History of Changes
Other Study ID Numbers: 201502003MIPB
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016

Keywords provided by National Taiwan University Hospital:
acute kidney injury
indoxylsulfate
p-cresol
AST-120

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants