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Clinical Study on the Effect of PTH on CYP3A4 Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03695107
Recruitment Status : Unknown
Verified September 2019 by The Third Xiangya Hospital of Central South University.
Recruitment status was:  Recruiting
First Posted : October 3, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
The Third Xiangya Hospital of Central South University

Study Description
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Brief Summary:
Parathyroid hormone (PTH) may play an important role in the down-regulation of CYP3A4 expression induced by Chronic kidney diseases (CKD). In the study of molecular mechanism, the research group found that the expression of CYP3A2 metabolic enzyme in rat liver decreased in the state of CKD.And PTH may down-regulate the expression of CYP3A4 metabolic enzyme by inhibiting the expression of Nuclear factor- Kilobuse (NF-kB) p65 subunit

Condition or disease Intervention/treatment
Chronic Kidney Diseases Drug: Nifedipine controlled released tablets

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Other
Official Title: Clinical Study on the Effect of PTH on CYP3A4 Activity
Estimated Study Start Date : October 2, 2019
Estimated Primary Completion Date : September 10, 2020
Estimated Study Completion Date : September 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Nifedipine

Groups and Cohorts
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Group/Cohort Intervention/treatment
XBDP1- Drug: Nifedipine controlled released tablets
lower blood pressure
XBDP2- Drug: Nifedipine controlled released tablets
lower blood pressure


Outcome Measures
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Primary Outcome Measures :
  1. the concentration of nifedipine [ Time Frame: at 5-7days ]
    the concentration of nifedipine


Secondary Outcome Measures :
  1. 24-hour ambulatory blood pressure [ Time Frame: at 1 day and 7day ]
    mean blood pressure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic renal function associated with hypertension
Criteria

Inclusion Criteria:

  • Chinese male or female subjects with an age of 18 or older were included;
  • The clinical physician diagnosed CKD with hypertension;
  • The physician decided that nifedipine controlled release tablets should be given.
  • Subjects agree to the study protocol, clinical and follow-up time, and sign the informed consent after the approval of the ethics committee;
  • Subjects will be able to communicate well with the investigator and will be able to complete the study as required.

Exclusion Criteria:

  • Patients with CKD requiring dialysis treatment;
  • Other clinical reasons that may be considered inappropriate for inclusion by clinicians.
Contacts and Locations
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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): NCT03695107


Contacts
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Contact: Yang Guoping, doctor 0086 0731 88618326 ygp9880@126.com

Locations
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China, Hunan
The Third Xiangya Hospital of Central South University , , China, Recruiting
Changsha, Hunan, China, 410013
Contact: Yang Guoping, professor, doctor    0086 0731 88618326    ygp9880@126.com   
Sponsors and Collaborators
The Third Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Yang GuoPing, doctor The Third Xiangya Hospital of Central South University
More Information
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Responsible Party: The Third Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03695107    
Other Study ID Numbers: XY3-PTH1708A01
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Nifedipine
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents