Clinical Study on the Effect of PTH on CYP3A4 Activity

Central South University

Status: Unknown

Conditions: Chronic Kidney Diseases

Treatments: Drug: Nifedipine controlled released tablets

Study type: Observational

Funder types: Other

Identifiers

NCT03695107

XY3-PTH1708A01

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

XBDP1-

Treatment:

Drug: Nifedipine controlled released tablets

XBDP2-

Treatment:

Drug: Nifedipine controlled released tablets