Clinical Study on the Effect of PTH on CYP3A4 Activity

Chronic Kidney Diseases Clinical Trial

Official title:

Clinical Study on the Effect of PTH on CYP3A4 Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03695107
• Other study ID #: XY3-PTH1708A01
• Status: Recruiting
• Start date: October 2, 2019
• Est. completion date: September 10, 2020

Study information

• Verified date: September 2019
• Source: The Third Xiangya Hospital of Central South University
• Contact: Yang Guoping, doctor
• Phone: 0086 0731 88618326
• Email: ygp9880[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Nifedipine controlled released tablets
lower blood pressure

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University , , China,	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the concentration of nifedipine	the concentration of nifedipine	at 5-7days
Secondary	24-hour ambulatory blood pressure	mean blood pressure	at 1 day and 7day