drugset / Trial / NCT00240045

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

NCT00240045

Phase 2/3 Completed 9 enrolled University of Alberta Novartis · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2005-10
Primary completion
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Albumin Protein / enzyme biologic 150 mg
Subject Midodrine Small molecule 12.5 mg
Subject Octreotide Peptide 20 mg

Indications