Midodrine, Octreotide and Albumin: Impact on Renal Function of Patients With Liver Cirrhosis and Renal Failure

NCT01587222 | Withdrawn Phase 2

• 1 other identifier: MAFRI-II
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Glomerular filtration

  Change in glomerular filtration rate measured by isotopic tests

  12 weeks

Secondary Outcomes (3)

• Changes in plasma renin activity, plasma aldosterone and norepinephrine

  4, 12 and 16 weeks

• Changes in blood pressure measured by Holter

  4, 12 and 16 weeks

• Changes in renal function

  at 4 weeks after cessation of treatment

Study Arms (1)

Albumin, Midodrine, Octreotide

EXPERIMENTAL

Drug: Albumin; Drug: Midodrine; Drug: Octreotide

Interventions

Albumin DRUG

Albumin (20%) 1g/kg iv on day 1 and 80 g every 2 weeks during a period of 12 weeks.

Albumin, Midodrine, Octreotide

Midodrine DRUG

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.

Albumin, Midodrine, Octreotide

Octreotide DRUG

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.

Albumin, Midodrine, Octreotide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Cardiac or respiratory failure
• Positive for human immunodeficiency virus
• Urinary retention
• Ischemic heart disease or peripheral vascular disease.
• Narrow Angle Glaucoma
• Cerebrovascular occlusions
• Aortic Aneurysm
• Thyrotoxicosis
• Pheochromocytoma

Sponsors & Collaborators

• Anna Cruceta: lead

Study Sites (1)

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Fibrosis; Renal Insufficiency; Hepatorenal Syndrome

Interventions

Albumins; Midodrine; Octreotide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CTU- Clinical trial unit

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: April 30, 2012
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 15, 2019

Record last verified: 2015-09

Locations

ES (1)