Clinical Study on the Effect of PTH on CYP3A4 Activity

September 17, 2019 updated by: The Third Xiangya Hospital of Central South University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University , , China,
        • Contact:
          • Yang Guoping, professor, doctor
          • Phone Number: 0086 0731 88618326
          • Email: ygp9880@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chronic renal function associated with hypertension

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
XBDP1-
Drug: Nifedipine controlled released tablets
lower blood pressure
XBDP2-
Drug: Nifedipine controlled released tablets
lower blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the concentration of nifedipine
Time Frame: at 5-7days
the concentration of nifedipine
at 5-7days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour ambulatory blood pressure
Time Frame: at 1 day and 7day
mean blood pressure
at 1 day and 7day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Yang GuoPing, doctor, The Third Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 2, 2019

Primary Completion (Anticipated)

September 10, 2020

Study Completion (Anticipated)

September 10, 2020

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (Actual)

October 3, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XY3-PTH1708A01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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