Midodrine and Albumin for Cirrhotic Patients With Functional Renal Impairment (MAFRI)

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2014 by Hospital Clinic of Barcelona

Sponsor:

Information provided by (Responsible Party):

Pere Gines, Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT01133795

First received: May 19, 2010

Last updated: March 3, 2014

Last verified: March 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Cirrhosis Renal Failure	Drug: Midodrine plus Albumin	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis

Drug Information available for: Midodrine hydrochloride

Genetic and Rare Diseases Information Center resources: Hepatorenal Syndrome

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:

Changes in glomerular filtration rate assessed by isotopic methods [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

changes in arterial pressure as assessed by continuous ambulatory arterial pressure [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
changes in plasma renin activity [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
changes in aldosterone concentration [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]
changes in norepinephrine concentration [ Time Frame: at 12 weeks of treatment ] [ Designated as safety issue: No ]


Estimated Enrollment:	20
Study Start Date:	February 2010
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: Albumin Grifols Gutron

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133795

Contacts


Contact: Pere Ginès, MD	0034932275400 ext 1713	PGINES@clinic.ub.es

Locations


Spain
Hospital Clinic	Recruiting
Villarroel 170,Barcelona, Barcelona, Spain, 08036
Sub-Investigator: Mónica Guevara, MD
Sub-Investigator: Gustavo H Pereira, MD

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators


Principal Investigator:	Pere Ginès, MD	Hospital Clinic of Barcelona

More Information

No publications provided


Responsible Party:	Pere Gines, chief of hepatology unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:	NCT01133795 History of Changes
Other Study ID Numbers:	MAFRI
Study First Received:	May 19, 2010
Last Updated:	March 3, 2014
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:


cirrhosis renal failure hepatorenal syndrome albumine midodrine

Additional relevant MeSH terms:


Liver Cirrhosis Renal Insufficiency Digestive System Diseases Kidney Diseases Liver Diseases Urologic Diseases Midodrine Adrenergic Agents Adrenergic Agonists Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists	Autonomic Agents Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sympathomimetics Therapeutic Uses Vasoconstrictor Agents

ClinicalTrials.gov processed this record on February 25, 2015

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