Primary outcomeCount of participants· 14 days
Number of Participants With Treatment Success
| Group | Value (Participants) |
|---|---|
| Treatment | 1 |
| Placebo | 1 |
Trial · Interventional
TerminatedNot applicableResults postedRegistry dataTreatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline
NCTNCT02123576 (opens ClinicalTrials.gov in a new tab)Other id17365
This trial was stopped early.
Reason given at the registry: Poor enrollment of study population
Results were posted for this trial.
This trial does not test a peptide that PepBank tracks.
- Names Octreotide, does not test it. It appears in the summary.
Overview
- Status
- Terminated
- Phase
- Not applicable
- Enrollment
- 12 participants (actual)
- Sponsor
- Patrick Northup, MD · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Apr 2014
- Primary completion
- 31 Dec 2017
- Completion
- 31 Dec 2017
- First posted
- 25 Apr 2014 (estimated)
- Last update posted
- 29 May 2019
- Conditions
- Hepatorenal Syndrome
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20142015201620172018
- N/ATerminated
Treatment of Type I Hepatorenal Syndrome (HRS) With Pentoxyfylline
NCT02123576Apr 2014 to 31 Dec 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Pentoxyfylline therapy in addition to the standard of care of albumin, midodrine and octreotide therapy is superior to the standard of care alone in the treatment of Type I hepatorenal syndrome in the first 14 days of hospitalization.
Interventions
- PentoxyfyllineDrug
- PlaceboDrug
- AMO TherapyDrug
Arms2
Experimental
Treatment
Pentoxyfylline 400mg three times a day or 400mg twice a day for eGFR 10-50 and 400mg once a day for eGFR \<10 for 90 days in addition to standard AMO therapy
Placebo comparator
Placebo
This is a standard placebo pill.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants With Treatment Success
Time frame · 14 days
Registry description
We define this as a decrease in serum creatinine level to \<1.5 mg/dL without dialysis or death
Secondary outcomes(5)
Change in Serum Creatinine From Baseline
Time frame · baseline and 14 days
Incidence of Treatment Failure
Time frame · up to day 14
Registry description
Defined as creatinine level above baseline value after day 7, dialysis or death
Number of Participants With Combined Outcome of Treatment Success and Partial Response
Time frame · 14 days
Registry description
We define as serum creatinine level decreased by \>50% from baseline but not to \<1.5 mg/dL, without dialysis or HRS recurrence
Transplant Free Survival
Time frame · day 30 and 180
Overall Survival
Time frame · up to 1 year
Registry description
This will be the combination of transplant free survival and those patients who received liver transplant
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(5)
Secondary outcomeMean· baseline and 14 days
Change in Serum Creatinine From Baseline
| Group | Value (g/dL) |
|---|---|
| Treatment | 0.48 |
| Placebo | 0.03 |
Secondary outcomeCount of participants· up to day 14
Incidence of Treatment Failure
| Group | Value (Participants) |
|---|---|
| Treatment | 3 |
| Placebo | 3 |
Secondary outcomeCount of participants· 14 days
Number of Participants With Combined Outcome of Treatment Success and Partial Response
| Group | Value (Participants) |
|---|---|
| Treatment | 1 |
| Placebo | 2 |
Secondary outcomeMean· day 30 and 180
Transplant Free Survival
| Group | Value (days) |
|---|---|
| Treatment | 80 |
| Placebo | 36 |
Secondary outcomeMean· up to 1 year
Overall Survival
| Group | Value (days) |
|---|---|
| Treatment | 102 |
| Placebo | 59 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| TreatmentPentoxyfylline 400mg three times a day or 400mg twice a day for eGFR 10-50 and 400mg once a day for eGFR \<10 for 90 days in addition to standard AMO therapy Pentoxyfylline AMO Therapy: Albumin, midodrine and octreotide therapy (standard of care for HRS) | 5 / 6 | 1 / 6 | 0 / 6 |
| PlaceboThis is a standard placebo pill. Placebo AMO Therapy: Albumin, midodrine and octreotide therapy (standard of care for HRS) | 3 / 6 | 0 / 6 | 0 / 6 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Hospitalized patients with acute or chronic liver disease
* Type I HRS
* Aged greater than or equal to 18
* Non-pregnant
Exclusion Criteria:
* Allergy or hypersensitivity to PTX or intolerance to methylxanthines (e.g. caffeine, theophylline)
* Concurrent use of nephrotoxic drugs
* Age less than 18
* Pregnancy
* Uncontrolled bacterial infection
* Renal parenchymal disease (e.g. acute tubular necrosis, glomerular disease, interstitial nephritis and urinary obstruction)
* Shock
* TNF alpha antagonist use
* Subject is institutionalized or a prisoner
* Recent cerebral or retinal hemorrhage (contraindication to PTX)
* Severe or poorly controlled cardiovascular disease as determined by the principal investigator to hinder the ability to adhere to study protocols
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