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Opioids in Chronic Kidney Disease Patients Undergoing Hemodialysis (OCKD)

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ClinicalTrials.gov Identifier: NCT02452437
Recruitment Status : Unknown
Verified May 2015 by Emerio & Lourdes Linares Research and Education Center.
Recruitment status was:  Recruiting
First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Emerio & Lourdes Linares Research and Education Center

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Oxycodone Phase 4

Detailed Description:

Clinical Trial Simulation Design and Investigational Plan: Our study sample will consist of a group of 10 randomly selected virtual Caucasian hemodialysis patients with Stage 5 chronic kidney disease (CKD) and a group of 10 randomly selected Caucasian age and weight matched healthy controls. Patients, 5 women and 5 men in each group, will be synthesized using clinical trial simulation techniques from the case report data reported by Lee, Leng, and Cooper and the experiments by Kirvela and coworkers. Our goal is to learn about the populations from which the study samples are drawn. To meet this goal, the investigators will perform Monte Carlo simulation.

Both virtual control subjects and experimental hemodialysis patients meeting all inclusion/exclusion criteria will be studied in two phases.

In phase 1, subjects will receive a ceiling dose of controlled-release oxycodone hydrochloride (hereafter CR-OC) totaling 40 mg twice daily for 2 weeks prior to the experimental hemodialysis procedure on day 15. Because patients in the hemodialysis group will be anuric, they will undergo hemodialysis three times weekly.10 During that time, they will receive supplemental oral immediate-release oxycodone every 4 h as needed to control their pain up to a visual analog scale level of < 3. These pain levels would correspond with plasma oxycodone concentrations of 20-50 ng/mL.

Patients will be instructed to take their last dose of CR-OC 2 to 3 hours before starting the experimental hemodialysis procedure. This dosing schedule will ensure that the time to CR-OC's maximum concentration (Tmax) and its maximum concentration (Cmax) will be reached at the time of blood sampling at t = 0, enabling accurate assessment of CR-OC's elimination with negligible influence from absorption or redistribution.

At 8:00 am on the 15th day, and this is phase 2 of the study, each individual will undergo hemodialysis for 4 hours. Two independent simultaneous blood samples for measurement of plasma oxycodone concentrations from both arterial inflow (Cin) and venous outflow (Cout) sites will be obtained immediately upon starting hemodialysis (t = 0) and immediately after hemodialysis before shutting off the machine (t = 4). For all calculations and ODE/PDE modeling (see Model Diagram), the oxycodone concentrations from those samples will be combined and averaged. Oxycodone's intradialytic extraction ratio will be calculated from the simultaneously sampled arterial (inflow) and venous (outflow) plasma oxycodone concentrations by dividing their difference by the arterial plasma oxycodone concentrations.

Controls will eat three light meals and a bedtime snack daily. Hemodialysis patients will eat a standard renal diet. Foods will be free of known inhibitors of CYP2D6. Individuals will be digitally abstained from nicotine, caffeine, grapefruit juice and alcohol during the course of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Clinical Trial Simulation Using ODE/PDE Hemodialysis Model for Quantifying Oxycodone's Removal in End-Stage Kidney Disease
Study Start Date : May 2015
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: control
Oxycodone will be administered and subjects will undergo hemodialysis
Drug: Oxycodone
Controlled release oxycodone 40 mg twice daily
Other Name: OxyContin

Experimental: hemodialysis
Oxycodone will be administered and subjects will undergo hemodialysis
Drug: Oxycodone
Controlled release oxycodone 40 mg twice daily
Other Name: OxyContin




Primary Outcome Measures :
  1. Oxycodone's intradialytic mass transfer coefficient [ Time Frame: t=0 to t=4 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452437


Contacts
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Contact: Oscar A Linares, MD 734-735-4022 oalinaresmd@gmail.com

Locations
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United States, Michigan
Oscar A. Linares, MD Recruiting
Dearborn, Michigan, United States, 48124
Contact: Oscar A Linares, MD    734-735-4022    oalinaresmd@gmail.com   
Sponsors and Collaborators
Emerio & Lourdes Linares Research and Education Center
Investigators
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Principal Investigator: Oscar A Linares, MD Emerio & Lourdes Linares Research and Education Center

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Responsible Party: Emerio & Lourdes Linares Research and Education Center
ClinicalTrials.gov Identifier: NCT02452437     History of Changes
Other Study ID Numbers: ELLHDM-001
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by Emerio & Lourdes Linares Research and Education Center:
oxycodone
hemodialysis
Additional relevant MeSH terms:
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Oxycodone
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents