Opioids in Chronic Kidney Disease Patients Undergoing Hemodialysis

Status unconfirmed · Phase 4

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT02452437

Run by

Emerio & Lourdes Linares Research and Education Center

People needed

20

Starts

2015-05-01

Expected to finish

2015-12-01

Last updated by the study team

2015-05-22

Who can join

Age: 30 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Oscar A. Linares, MD — Dearborn, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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