Chronic Kidney Diseases Clinical Trial
Official title:
Drug Metabolizing Enzyme and Transporter Function in Chronic Kidney Disease
Verified date | June 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigates the effect of vitamin D deficiency on drug metabolism and transport in patients with chronic kidney disease (CKD) and in healthy controls. The central hypothesis is that vitamin D concentrations independently affect metabolism and transport function in CKD patients. An over-arching goal of this proposal is to make drug therapies safer and more effective to reduce the significant morbidity and mortality in patients with CKD.
Status | Completed |
Enrollment | 23 |
Est. completion date | February 1, 2019 |
Est. primary completion date | February 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion criteria for CKD patients: - vitamin D deficient (<30 ng/mL) - hemoglobin >10 g/dL - willing to abstain from fruit juices or alcohol within 7 days of PK assessments - no changes in prescription or nonprescription medications within 4 wks of study start - age 18-70 yrs - If a diagnosis of CKD, must be due to diabetes mellitus or hypertension - Signed informed consent Inclusion Criteria for Healthy Controls: - vitamin D deficient (<30 ng/mL) - hemoglobin >10 g/dL - willing to abstain from fruit juices or alcohol within 7 days of PK assessments - no changes in prescription or nonprescription medications within 4 wks of study start - age 18-70 yrs - Signed informed consent Exclusion criteria for CKD patients: - History of >14 alcoholic drinks/wk - Not likely to be compliant with study visits - Pregnant or lactating - Predisposition to or history of hypercalcemia - History of allergy, sensitivity, or contraindication to probe drugs (seizures, drug metabolism interactions, etc) - Use of prescribed or nonprescribed therapies that could interact with probe drugs (including prototypical inhibitors or inducers) - Active autoimmune disease or active/recent infections requiring antimicrobial treatment within the previous 4 wks will be excluded to minimize inflammatory-mediated changes in vitamin D status and patient heterogeneity. - Presence of clinically significant hepatic insufficiency (total bilirubin greater than 1.5 times the upper limit of normal or transaminase (ALT, AST) elevations greater than 2 times the upper limit of the laboratory reference range or liver disease - Active seizure disorder or those patients receiving large doses of medications that are known to reduce seizure threshold - Currently receiving cholecalciferol or a vitamin D analogue Exclusion Criteria for Healthy Controls: - History of >14 alcoholic drinks/wk - Not likely to be compliant with study visits - Pregnant or lactating - Predisposition to or history of hypercalcemia - History of allergy, sensitivity, or contraindication to probe drugs (seizures, drug metabolism interactions, etc) - Use of prescribed or nonprescribed therapies that could interact with probe drugs (including prototypical inhibitors or inducers) - Active autoimmune disease or active/recent infections requiring antimicrobial treatment within the previous 4 wks will be excluded to minimize inflammatory-mediated changes in vitamin D status and patient heterogeneity. - Presence of clinically significant hepatic insufficiency (total bilirubin greater than 1.5 times the upper limit of normal or transaminase (ALT, AST) elevations greater than 2 times the upper limit of the laboratory reference range or liver disease - Active seizure disorder or those patients receiving large doses of medications that are known to reduce seizure threshold - Currently receiving cholecalciferol or a vitamin D analogue - Any clinical evidence of chronic kidney disease as defined by the National Kidney Foundation Dialysis Outcomes Quality Initiative (NKF DOQI) guidelines |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Aurora | Colorado |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | National Institute of General Medical Sciences (NIGMS), University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in area under the plasma concentration time curves for probe drugs (bupropion, midazolam, olmesartan and fexofenadine) from baseline to 12 weeks. | Change in area under the plasma concentration time curves for probe drugs (bupropion, midazolam, olmesartan, and fexofenadine) at 12 weeks. | 12 weeks | |
Secondary | Change in area under the plasma concentration time curves for cholecalciferol from baseline to 12 weeks. | Change in area under the plasma concentration time curves for cholecalciferol at 12 weeks. | 12 weeks |
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