Clinical Study on the Effect of PTH on CYP3A4 Activity

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 17, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2, 2018

Estimated Primary Completion Date

September 10, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the concentration of nifedipine[ Time Frame: at 5-7days ]

the concentration of nifedipine

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Clinical Study on the Effect of PTH on CYP3A4 Activity

Official Title ^ICMJE

Clinical Study on the Effect of PTH on CYP3A4 Activity

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

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Drug: Nifedipine controlled released tablets
lower blood pressure

Study Arms

: XBDP1-
: XBDP2-

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 10, 2020

Estimated Primary Completion Date

September 10, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Yes

Responsible Party

，

Study Sponsor ^ICMJE

The Third Xiangya Hospital of Central South University

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Verification Date

October 2018

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

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