The Use of Drugs to Improve Kidney Function in Patients With Liver and Kidney Dysfunction

NCT00240045 | Completed Phase 2

• 1 other identifier: VB-PG-007
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

We will address the hypothesis that refractory ascites and Type 2 hepatorenal syndrome are mediated in part by diminished circulatory volume and that treatment with midodrine, octreotide and albumin can improve renal and patient outcomes by restoring effective circulating volume and systemic perfusion. Our primary objective is to assess change in creatinine clearance using inulin. We will enroll 15 patients with Type 2 hepatorenal syndrome or refractory ascites once inclusion and exclusion criteria are satisfied. They will be treated for 1 month with octreotide LAR, albumin and midodrine. Renal, serum and neurohormonal parameters will be measured before, during, and after initiation of drug and compared.

Conditions

Type 2 Hepatorenal Syndrome; Refractory Ascites

Keywords

Hepatorenal syndrome; Refractory ascites; Midodrine; Octreotide; Albumin; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Improvement in renal function (creatinine)

  one month

Secondary Outcomes (1)

• Ascites control

  one month

Study Arms (1)

1

EXPERIMENTAL

Drug: Midodrine, albumin, octreotide LAR; Drug: midodrine, octreotide, albumin

Interventions

Midodrine, albumin, octreotide LAR DRUG

1

midodrine, octreotide, albumin DRUG

midodrine up to 12.5 mg tid, octreotide LAR 20 mg im once, albumin 150 mg q weekly

1

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis (biopsy or compatible clinical (ascites, varices), laboratory (low albumin, elevated bilirubin, elevated INR) and radiologic data (nodular appearing liver on ultrasound)).
• Type 2 hepatorenal syndrome and/or refractory ascites

You may not qualify if:

• Secondary causes of renal dysfunction (proteinuria \>500 mg/day, active urinary sediment, abnormal renal ultrasound, nephrotoxic medications) Bacterial infection (positive blood, urine or ascites cultures) within the past 2 weeks Gastrointestinal hemorrhage or encephalopathy within the past 2 weeks Age \<18 Transvenous intrahepatic portosystemic stent shunt (TIPS) Hepatocellular carcinoma beyond the Milan criteria

Sponsors & Collaborators

• University of Alberta: lead
• Novartis: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Ascites; Hepatorenal Syndrome; Fibrosis

Interventions

Midodrine; Albumins; Octreotide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Vincent Bain, MD, FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: October 1, 2005
• Study Completion: July 1, 2007
• Last Updated: December 6, 2007

Record last verified: 2005-10

Locations

CA (1)