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Pharmacokinetic Study in Patients With Chronic Kidney Disease and Healthy Volunteers (CKD)

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ClinicalTrials.gov Identifier: NCT01087749
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE March 15, 2010
First Posted Date  ICMJE March 16, 2010
Last Update Posted Date May 30, 2013
Study Start Date  ICMJE March 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
Pharmacokinetic parameters [ Time Frame: 3 weeks ]
Three 12-hour days visits (on different weeks) will be investigated to obtain blood samples for 12 hours for three different medications. Blood samples will be obtained to determine the medication concentration in the plasma. There is no therapeutic effect on this study, since patients will receive a low single dose of the medication, and we'll assess the different pharmacokinetic parameters based on the concentrations of the medicine in plasma.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study in Patients With Chronic Kidney Disease and Healthy Volunteers
Official Title  ICMJE Pharmacokinetic Study of Propranolol, Losartan, and Eprosartan in Healthy Volunteers and Patients With Chronic Kidney Disease
Brief Summary The purpose of this study is to find out how chemicals in the blood of patients with chronic kidney disease affect how medications are removed from the body. The patient will take one dose of three different drugs, one on each week, for a total of three single doses. The investigators want to find out if these three different medications are affected in different ways by the chemicals in the blood of patients with kidney disease.
Detailed Description It has been demonstrated that proteins known as drug transporters in different human organs and tissues are important for a drug to be absorbed, distributed, metabolized, and eliminated (ADME)18. The chemical properties of drugs can affect whether it needs a transporter protein to enter the cell or not. It is not well known how these proteins are affected in chronic disease and how different drugs may be absorbed, metabolized, or eliminated differently in certain diseases. Preliminary studies suggest that some drugs (those requiring drug transporter proteins) may show altered elimination in the presence of uremic toxins. Uremic toxins are substances accumulated in the blood of patients with chronic kidney disease and many are not removed through hemodialysis (HD). We hypothesize that the different classes of drugs (BDDCS class1, 2, and 3) will have different degrees of changes in AUC, meaning that for a class 1 drug we would see less of a change in AUC than in a class 3 drug because a class 3 drug requires transporters. Previous studies can't make that comparison because they used different patients for each drug, so even if there were a change in a class 1 drug, it can't be compared to a class 3 drug. In order to get an accurate comparison, we will test the three drugs on the same patient and see how he AUC changes from drug to drug within the same patient comparing it to the healthy volunteer (taking the same three drugs).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Kidney Disease
Intervention  ICMJE
  • Drug: Propranolol
    Propranolol 40mg PO will be given with 6oz of water.Blood samples will be obtained for 12 hours to determine the medication concentration in the plasma. There is no therapeutic effect on this study, since patients will receive a low single dose of the medication, and we'll assess the different pharmacokinetic parameters based on the concentrations of the medicine in plasma.
    Other Names:
    • Propranolol Hydrochloride
    • Ciplar
    • Ciplar LA
    • Inderal
    • Inderal LA
    • Avlocardyl
    • Deralin
    • Dociton
    • Inderalici
    • InnoPran XL
    • Sumial
    • Anaprilinum
    • Bedranol SR
  • Drug: Losartan
    Losartan 50mg PO will be given with 6oz of water. Blood samples will be obtained for 12 hours to determine the medication concentration in the plasma. There is no therapeutic effect on this study, since patients will receive a low single dose of the medication, and we'll assess the different pharmacokinetic parameters based on the concentrations of the medicine in plasma.
    Other Names:
    • Cozaar
    • Losartan potassium
    • Anin
  • Drug: Eprosartan
    Erythromycin 125mg PO will be given with 6oz of water. Blood samples will be obtained for 12 hours to determine the medication concentration in the plasma. There is no therapeutic effect on this study, since patients will receive a low single dose of the medication, and we'll assess the different pharmacokinetic parameters based on the concentrations of the medicine in plasma.
    Other Names:
    • Teveten
    • Eprozar
    • Teveten HCT (paired with hydrochlorothiazide)
    • Teveten Plus (paired with hydrochlorothiazide)
Study Arms  ICMJE
  • Experimental: Chronic Kidney Disease
    Propranolol, Losartan, and Eprosartan will be administered to patients who have been diagnosed with Chronic Kidney disease and have a glomerular filtration rate (GFR) below 40ml/min.
    Interventions:
    • Drug: Propranolol
    • Drug: Losartan
    • Drug: Eprosartan
  • Experimental: Healthy Volunteers
    Propranolol, Losartan, and Eprosartan will be administered to healthy volunteers without chronic kidney disease.
    Interventions:
    • Drug: Propranolol
    • Drug: Losartan
    • Drug: Eprosartan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female 18-70 years of age.
  • Healthy volunteers or chronic kidney disease (GFR<40)
  • Be able to provide written informed consent and comply with requirements of the study.
  • Avoid eating grapefruit and drinking grapefruit juice from 7 days prior to the first study day until completion of the study.
  • Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of the study day.
  • Fast from food and beverages at least 8 hours prior to medication dosing.
  • Be able to read, speak, and understand English.

Exclusion Criteria:

  • Subjects with contraindications to taking the study drugs
  • Subjects with known allergies to propranolol, losartan, or eprosartan.
  • Subjects who smoke tobacco.
  • Subjects with ongoing alcohol or illegal drug use.
  • Subjects who are pregnant, lactating, or attempting to conceive.
  • Subjects unable to maintain adequate birth control during the study.
  • Subjects unable to follow protocol instructions or protocol criteria.
  • Subjects with hematocrit < 30mg/dL.
  • Subjects who are insulin requiring diabetics.
  • Subjects with low, or low normal blood pressure (systolic blood pressure [BP] <100mmHg)
  • Subjects with uncontrolled high blood pressure.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01087749
Other Study ID Numbers  ICMJE PKUCSF2010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leslie Z Benet, PhD University of California, San Francisco
Principal Investigator: Lynda Frassetto, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP