Clinical Study on the Effect of PTH on CYP3A4 Activity

• Conditions: Chronic Kidney Diseases
• Interventions: Drug: Nifedipine controlled released tablets

• Registration Number: NCT03695107
• Lead Sponsor: The Third Xiangya Hospital of Central South University

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

Not available

Study Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19
• Study Start: 2019-10-02
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
XBDP1-	Nifedipine controlled released tablets	-
XBDP2-	Nifedipine controlled released tablets	-

Primary Outcome Measures

Name	Time	Method
the concentration of nifedipine	at 5-7days	the concentration of nifedipine

Secondary Outcome Measures

Name	Time	Method
24-hour ambulatory blood pressure	at 1 day and 7day	mean blood pressure

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University , , China,; 🇨🇳 Changsha, Hunan, China