Opioids in Chronic Kidney Disease Patients Undergoing Hemodialysis

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To measure oxycodone's intradialytic mass transfer rate coefficient and oxycodone's removal rate using an ODE/PDE hemodialysis model. To implement a rational clinical strategy for estimating a patient's post-hemodialysis oxycodone restoration dose using results from an ODE/PDE model of hemodialysis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emerio & Lourdes Linares Research and Education Center
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

• Healthy, non-smoking, opioid intolerant Caucasian men and women controls.

• Hemodialysis patients age 44 ± 10 (mean ± SD) years and normal controls 36 ± 9 years.

• No statistically significant difference in weight between hemodialysis and control patients.

• Mean serum creatinine concentrations of 7.29 ± 1.48 mg/dL in hemodialysis patients and 0.81 ± 0.12 mg/dL in controls (normal 0.7 to 1.3 mg/dL for men and 0.6 to 1.1 mg/dL for women)

• Mean urine output of 1.83 ± 0.47 mL/hr (44 ± 11 mL/24 hr) in hemodialysis patients and 62.32 ± 16.01 mL/hr (1496 ± 384 mL/24 hr) in controls.

• Patients in both groups with normal liver function. Serum prothrombin time (PT/INR), aPTT, albumin, bilirubin (direct and indirect), liver transaminases, gamma-glutamyl transferase and alkaline phosphatase normal.

Exclusion Criteria:

• In both groups, a clinically significant electrocardiogram (ECG) abnormality.

• An uncontrolled clinically significant cardiovascular condition other than end-stage kidney disease.

• Elevated transaminases, alkaline phosphatase, bilirubin, low phosphodiesterase, elevated ammonia levels, low glucose, elevated lactate, elevated creatinine, and hypoxia (hepatorenal syndrome)

• Serum positive for HIV, hepatitis BsAg, or Hepatitis C

• A history of drug or alcohol abuse within the past 24 months

• Currently participating (or participated within the previous 30 days in an investigational therapeutic or device study

• Female who is pregnant, nursing, or of child-bearing potential not practicing effective contraceptive methods.