Pharmacokinetic Study in Patients With Chronic Kidney Disease and Healthy Volunteers (CKD)
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| ClinicalTrials.gov Identifier: NCT01087749 |
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Recruitment Status :
Completed
First Posted : March 16, 2010
Last Update Posted : May 30, 2013
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Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Disease | Drug: Propranolol Drug: Losartan Drug: Eprosartan | Phase 1 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Official Title: | Pharmacokinetic Study of Propranolol, Losartan, and Eprosartan in Healthy Volunteers and Patients With Chronic Kidney Disease |
| Study Start Date : | March 2010 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
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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.
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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:
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:
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:
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Experimental: Healthy Volunteers
Propranolol, Losartan, and Eprosartan will be administered to healthy volunteers without chronic kidney disease.
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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:
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:
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:
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Primary Outcome Measures :
- 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.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
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): NCT01087749
Locations
| United States, California | |
| Clinical Reserach Center, UCSF | |
| San Francisco,, California, United States, 94143 | |
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | Leslie Z Benet, PhD | University of California, San Francisco | |
| Principal Investigator: | Lynda Frassetto, MD | University of California, San Francisco |
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01087749 |
| Other Study ID Numbers: |
PKUCSF2010 |
| First Posted: | March 16, 2010 Key Record Dates |
| Last Update Posted: | May 30, 2013 |
| Last Verified: | May 2013 |
Additional relevant MeSH terms:
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Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency Losartan Propranolol Hydrochlorothiazide Eprosartan Anti-Arrhythmia Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Vasodilator Agents Angiotensin II Type 2 Receptor Blockers |