Acute Kidney InjuryPhase 3NCT02687841
A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury
A Phase 3 study testing AST-120and pentoxyphylline (PTX) and pentoxyphylline (PTX) in people with Acute Kidney Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- AST-120and pentoxyphylline (PTX) and pentoxyphylline (PTX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- 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.
- Patients with oliguric acute kidney injury, as defined with less than 500cc/day.
- Evidence of obstructive acute kidney injury under kidney echosonography.
Trial locations and contacts
1 site in 1 country.
KWAN-DUN WU contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Yun-Lin Branch
Douliu, Taiwan, 640
Tao-Min Huang, 0972655730, taominhuang@gmail.com
About this study
Official title: A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury - A Open Label Randomized Control Trial
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
- Being tested
- AST-120and pentoxyphylline (PTX), pentoxyphylline (PTX)
- Keywords
- acute kidney injury, indoxylsulfate, p-cresol, AST-120
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
pentoxyphylline (PTX)Drug
pentoxyphylline 400mg QD PO x 10 days.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: AST-120and pentoxyphylline (PTX) |
| PTX | Active comparator | Pentapentoxifylline 400mg QD for 10 days Receives: Drug: pentoxyphylline (PTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total recovery of kidney function, which is defined as less than 1.5 times pre-morbid creatinine levels on the 10th day of intervention.
Measured: 10 days
Secondary outcomes (7)
Total recovery of serum creatinine on Day 5
defined with less than 1.5 times elevation of pre-morbid plasma creatinine level.
Measured: 5 days
Needing renal replacement therapy on day 10.
Measured: 10 days
Degree of serum creatinine elevation
as calculated with ratios between highest serum creatinine and pre-morbid creatinine during study period
Measured: 10 days
The degree of Indoxyl sulfate change on Day 10 (%)
Measured: 10 days
The degree of Indoxyl sulfate change on Day 5 (%)
Measured: 5 days
The degree of p-cresol change on Day 10 (%)
Measured: 10 days
The degree of p-cresol change on Day 5 (%)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- YU-SHENG WU, Principal investigator, National Taiwan University HospitalTao-Min Huang, Principal investigator, National Taiwan University Hospital, Yun-Lin BranchWei-Shun Yang, Principal investigator, National Taiwan University Hospital Hsin-Chu BranchJUI-HSIANG LIN, Principal investigator, Taoyuan General HospitalYa-Fei Yang, Principal investigator, China Medical University HospitalChan-Yu Lin, Principal investigator, Chang Gung Memorial HospitalHeng-Chih Pan, Principal investigator, Chang Gung Memorial HospitalChih-Chin Kao, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687841
- Sponsor's protocol ID
- 201502003MIPB
- Status last verified
- Feb 2016
- First submitted
- 26 Jan 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury - A Open Label Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02687841
- Acronym / sponsor ID
- 201502003MIPB
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, indoxylsulfate, p-cresol, AST-120
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- 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
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AST-120 and PTX | Experimental | 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 Pentapentoxifylline 400mg QD for 10 days |
| PTX | Active comparator | Drug: pentoxyphylline (PTX)Pentapentoxifylline 400mg QD for 10 days |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | AST-120 and PTX |
| pentoxyphylline (PTX)pentoxyphylline 400mg QD PO x 10 days. | Drug | PTX |
Primary outcome
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
7 secondary outcomes
Total recovery of serum creatinine on Day 5
Time frame: 5 days
Needing renal replacement therapy on day 10.
Time frame: 10 days
Degree of serum creatinine elevation
Time frame: 10 days
The degree of Indoxyl sulfate change on Day 10 (%)
Time frame: 10 days
The degree of Indoxyl sulfate change on Day 5 (%)
Time frame: 5 days
The degree of p-cresol change on Day 10 (%)
Time frame: 10 days
The degree of p-cresol change on Day 5 (%)
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KWAN-DUN WU contact
YU-SHENG WU principal investigator
National Taiwan University Hospital
Tao-Min Huang principal investigator
National Taiwan University Hospital, Yun-Lin Branch
Wei-Shun Yang principal investigator
National Taiwan University Hospital Hsin-Chu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AST-120and pentoxyphylline (PTX) and pentoxyphylline (PTX) in people with Acute Kidney Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao-Min Huang (0972655730, taominhuang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.