Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment (MAFRI)
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ClinicalTrials.gov Identifier: NCT01133795 |
Recruitment Status
:
Completed
First Posted
: May 31, 2010
Last Update Posted
: August 18, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cirrhosis Renal Failure | Drug: Midodrine plus Albumin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect of Administration of Intravenous Albumin and Oral Midodrine on Renal Function in Patients With Cirrhosis and Functional Renal Impairment |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Midodrine, Albumin
Midodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
|
Drug: Midodrine plus Albumin
MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
Other Names:
|
- Changes in glomerular filtration rate assessed by isotopic methods [ Time Frame: at 12 weeks of treatment ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Liver Cirrhosis
- Serum Creatinine greater than 1,2 mg/dL
- to have given written informed consent
Exclusion Criteria:
- 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

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): NCT01133795
Spain | |
Hospital Clinic | |
Villarroel 170,Barcelona, Barcelona, Spain, 08036 |
Principal Investigator: | Pere Ginès, MD | Hospital Clinic of Barcelona |
Responsible Party: | Pere Gines, chief of hepatology unit, Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT01133795 History of Changes |
Other Study ID Numbers: |
MAFRI |
First Posted: | May 31, 2010 Key Record Dates |
Last Update Posted: | August 18, 2016 |
Last Verified: | August 2016 |
Keywords provided by Pere Gines, Hospital Clinic of Barcelona:
cirrhosis renal failure hepatorenal syndrome albumine midodrine |
Additional relevant MeSH terms:
Fibrosis Liver Cirrhosis Renal Insufficiency Pathologic Processes Liver Diseases Digestive System Diseases Kidney Diseases Urologic Diseases Midodrine Sympathomimetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Vasoconstrictor Agents Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |