CirrhosisPhase 2MAFRINCT01133795
Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment
A Phase 2 study testing Midodrine plus Albumin in people with Cirrhosis and Renal Failure, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The objective of the study was evaluate the effect of administration of midodrine and albumin on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cirrhosis, Renal Failure
- What is being tested?
- Midodrine plus Albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2010to Jun 2016
- 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
- Liver Cirrhosis
- Serum Creatinine greater than 1,2 mg/dL
- to have given written informed consent
Who cannot join
- pregnancy
- Systolic blood pressure above 150mmHg and/or diastolic blood pressure above 90mmHg
- Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts
- Antibiotic treatment in the previous 7 days before inclusion, except for prophylaxis of spontaneous bacterial peritonitis
- infection by HIV
- contraindications for albumin and/or midodrine use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment
The objective of the study was evaluate the effect of administration of midodrine and albumin on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.
Read the detailed description
Twenty patients with cirrhosis and functional renal impairment, defined by a serum creatinine greater than 1,2mg/dl, will be included. Patients will receive daily midodrine at a dose of 10mg tid and 40g of albumin at 15-day interval. The follow-up period will be of 12 weeks. In all patients, liver and renal function, and vasoactive hormones (plasma renin activity, aldosterone, noradrenaline, ADH, endothelin and anf)will be determined at baseline conditions. At this moment, glomerular filtration rate and renal plasma flow determined by isotopic techniques as ambulatory blood pressure monitoring through a 24-hour period will be performed too. All these determinations will be repeated at 4 and 12 weeks. During the study period, just before the albumin infusions, blood will be drawn for creatinine and electrolytes determinations and these will be recorded as well physical examination performed.
- Conditions
- Cirrhosis, Renal Failure
- Being tested
- Midodrine plus Albumin
- Keywords
- cirrhosis, renal failure, hepatorenal syndrome, albumine, midodrine
- 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.
Midodrine plus AlbuminDrug
Also called Albumin Grifols, Gutron
MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Midodrine, Albumin | Experimental | Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks Receives: Drug: Midodrine plus Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glomerular filtration rate assessed by isotopic methods
Measured: at 12 weeks of treatment
Secondary outcomes (4)
changes in arterial pressure as assessed by continuous ambulatory arterial pressure
Measured: at 12 weeks of treatment
changes in plasma renin activity
Measured: at 12 weeks of treatment
changes in aldosterone concentration
Measured: at 12 weeks of treatment
changes in norepinephrine concentration
Measured: at 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pere Gines, Hospital Clinic of Barcelona
- Investigators
- Pere Ginès, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133795
- Sponsor's protocol ID
- MAFRI
- Acronym
- MAFRI
- Status last verified
- Aug 2016
- First submitted
- 19 May 2010
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment
- ClinicalTrials.gov ID
- NCT01133795
- Acronym / sponsor ID
- MAFRI / MAFRI
- Conditions
- Cirrhosis, Renal Failure
- Keywords
- cirrhosis, renal failure, hepatorenal syndrome, albumine, midodrine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 31 May 2010 (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 objective of the study was evaluate the effect of administration of midodrine and albumin on renal function in patients with cirrhosis and creatinine greater than 1,2mg/dl.
Detailed description
Twenty patients with cirrhosis and functional renal impairment, defined by a serum creatinine greater than 1,2mg/dl, will be included. Patients will receive daily midodrine at a dose of 10mg tid and 40g of albumin at 15-day interval. The follow-up period will be of 12 weeks. In all patients, liver and renal function, and vasoactive hormones (plasma renin activity, aldosterone, noradrenaline, ADH, endothelin and anf)will be determined at baseline conditions. At this moment, glomerular filtration rate and renal plasma flow determined by isotopic techniques as ambulatory blood pressure monitoring through a 24-hour period will be performed too. All these determinations will be repeated at 4 and 12 weeks. During the study period, just before the albumin infusions, blood will be drawn for creatinine and electrolytes determinations and these will be recorded as well physical examination performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midodrine, Albumin | Experimental | Drug: Midodrine plus AlbuminMidodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Liver Cirrhosis
- Serum Creatinine greater than 1,2 mg/dL
- to have given written informed consent
Key exclusion criteria (6 listed)
- pregnancy
- Systolic blood pressure above 150mmHg and/or diastolic blood pressure above 90mmHg
- Previous treatment with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts
- Antibiotic treatment in the previous 7 days before inclusion, except for prophylaxis of spontaneous bacterial peritonitis
- infection by HIV
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 |
|---|---|---|
| Midodrine plus AlbuminAlso: Albumin Grifols, GutronMIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks | Drug | Midodrine, Albumin |
Primary outcome
Changes in glomerular filtration rate assessed by isotopic methods
Time frame: at 12 weeks of treatment
4 secondary outcomes
changes in arterial pressure as assessed by continuous ambulatory arterial pressure
Time frame: at 12 weeks of treatment
changes in plasma renin activity
Time frame: at 12 weeks of treatment
changes in aldosterone concentration
Time frame: at 12 weeks of treatment
changes in norepinephrine concentration
Time frame: at 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 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.
Pere Ginès, MD principal investigator
Hospital Clinic of Barcelona
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 Midodrine plus Albumin in people with Cirrhosis and Renal Failure, run by Hospital Clinic of Barcelona 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 18 Aug 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in glomerular filtration rate assessed by isotopic methods (time frame: at 12 weeks of treatment). 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 18 Aug 2016.