FibrosisPhase 2NCT01587222
Midodrine, Octreotide and Albumin: Impact on Renal Function of Patients With Liver Cirrhosis and Renal Failure
A Phase 2 study testing Albumin, Midodrine and Octreotide in people with Fibrosis and Renal Failure, run by Anna Cruceta at 1 site in Spain.
Trial summary
The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin during 12 weeks in patients with hepatorenal syndrome. Fifteen patients will be enrolled and followed during 16 weeks. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibrosis, Renal Failure, Hepatorenal Syndrome
- What is being tested?
- Albumin, Midodrine and Octreotide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Aug 2017
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- Cirrhosis of the liver defined by clinical, biochemical or histological
- Functional renal failure with serum creatinine greater than 1.2 mg / dl and less than 2.5 mg / dl.
- That, properly informed, give their consent to participate in the study and undergo tests and examinations that entails
- Women of childbearing potential: pregnancy test negative serum or urine, and acceptance of use of adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last dose
Who cannot join
- Pregnant women, nursing mothers, or those who intend to become pregnant during the study period
- Systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 90 mmHg
- Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunts
- Use of antibiotics in the seven days prior to inclusion in the study except for prophylactic (ie. prophylaxis of spontaneous bacterial peritonitis)
- Cardiac or respiratory failure
- Positive for human immunodeficiency virus
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- Urinary retention
- Ischemic heart disease or peripheral vascular disease.
- Narrow Angle Glaucoma
- Cerebrovascular occlusions
- Aortic Aneurysm
- Thyrotoxicosis
- Pheochromocytoma
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin during 12 weeks in patients with hepatorenal syndrome. Fifteen patients will be enrolled and followed during 16 weeks. The effects on renal function will be evaluated 12 and 16 weeks after the beginning of the treatment by isotopic evidence and biochemist determinations. Also it will be evaluated arterial pressure and determination of vasoactive hormones (plasma renin, aldosterone and norepinephrine).
- Conditions
- Fibrosis, Renal Failure, Hepatorenal Syndrome
- Being tested
- Albumin, Midodrine, Octreotide
- Medical subject headings
- Fibrosis, Renal Insufficiency, Hepatorenal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuminDrug
Albumin (20%) 1g/kg iv on day 1 and 80 g every 2 weeks during a period of 12 weeks.
MidodrineDrug
Oral midodrine 5 mg / 8 hours for 12 weeks. The dose may be increased on day 7 10mg/8h.
If creatinine does not decrease ≥ 25% and systolic blood pressure is bellow 150 mmHg and diastolic 90 mmHg doses will be changed.
OctreotideDrug
Octreotide by subcutaneous injection 0.1 mg every 8 hours for 12 weeks. The dose may be increased to 0.2 mg / 8 h on day 7.
If creatinine does not decrease ≥ 25% and systolic blood pressure is bellow 150 mmHg and diastolic 90 mmHg doses will be changed.
| Study group | Role | What they receive |
|---|---|---|
| Albumin, Midodrine, Octreotide | Experimental | Not described Receives: Drug: Albumin; Drug: Midodrine; Drug: Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration
Change in glomerular filtration rate measured by isotopic tests
Measured: 12 weeks
Secondary outcomes (3)
Changes in plasma renin activity, plasma aldosterone and norepinephrine
Measured: 4, 12 and 16 weeks
Changes in blood pressure measured by Holter
Measured: 4, 12 and 16 weeks
Changes in renal function
Measured: at 4 weeks after cessation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJul 2016 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: the sponsor did not provide the treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Cruceta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587222
- Sponsor's protocol ID
- MAFRI-II
- Status last verified
- Sep 2015
- First submitted
- 27 Apr 2012
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midodrine, Octreotide and Albumin: Impact on Renal Function of Patients With Liver Cirrhosis and Renal Failure
- ClinicalTrials.gov ID
- NCT01587222
- Acronym / sponsor ID
- MAFRI-II
- Conditions
- Fibrosis, Renal Failure, Hepatorenal Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the sponsor did not provide the treatment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anna CrucetaUniversity, hospital or other
- Study start
- Jul 2016 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 30 Apr 2012 (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.
The aim of this study is to evaluate the treatment with midodrine, octreotide and albumin during 12 weeks in patients with hepatorenal syndrome. Fifteen patients will be enrolled and followed during 16 weeks. The effects on renal function will be evaluated 12 and 16 weeks after the beginning of the treatment by isotopic evidence and biochemist determinations. Also it will be evaluated arterial pressure and determination of vasoactive hormones (plasma renin, aldosterone and norepinephrine).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albumin, Midodrine, Octreotide | Experimental | Drug: Albumin, Drug: Midodrine, Drug: Octreotide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years
- Cirrhosis of the liver defined by clinical, biochemical or histological
- Functional renal failure with serum creatinine greater than 1.2 mg / dl and less than 2.5 mg / dl.
- That, properly informed, give their consent to participate in the study and undergo tests and examinations that entails
- Women of childbearing potential: pregnancy test negative serum or urine, and acceptance of use of adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last dose
Key exclusion criteria (13 listed)
- Pregnant women, nursing mothers, or those who intend to become pregnant during the study period
- Systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 90 mmHg
- Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical portosystemic shunts
- Use of antibiotics in the seven days prior to inclusion in the study except for prophylactic (ie. prophylaxis of spontaneous bacterial peritonitis)
- Cardiac or respiratory failure
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 |
|---|---|---|
| AlbuminAlbumin (20%) 1g/kg iv on day 1 and 80 g every 2 weeks during a period of 12 weeks. | Drug | Albumin, Midodrine, Octreotide |
| MidodrineOral midodrine 5 mg / 8 hours for 12 weeks. The dose may be increased on day 7 10mg/8h. If creatinine does not decrease ≥ 25% and systolic blood pressure is bellow 150 mmHg and diastolic 90 mmHg doses will be changed. | Drug | Albumin, Midodrine, Octreotide |
| OctreotideOctreotide by subcutaneous injection 0.1 mg every 8 hours for 12 weeks. The dose may be increased to 0.2 mg / 8 h on day 7. If creatinine does not decrease ≥ 25% and systolic blood pressure is bellow 150 mmHg and diastolic 90 mmHg doses will be changed. | Drug | Albumin, Midodrine, Octreotide |
Primary outcome
Glomerular filtration
Time frame: 12 weeks
Change in glomerular filtration rate measured by isotopic tests
3 secondary outcomes
Changes in plasma renin activity, plasma aldosterone and norepinephrine
Time frame: 4, 12 and 16 weeks
Changes in blood pressure measured by Holter
Time frame: 4, 12 and 16 weeks
Changes in renal function
Time frame: at 4 weeks after cessation of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albumin, Midodrine and Octreotide in people with Fibrosis and Renal Failure, run by Anna Cruceta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 15 Feb 2019. 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration (time frame: 12 weeks). 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 15 Feb 2019.