Clinical Study on the Effect of PTH on CYP3A4 Activity

NCT03695107 | Unknown

• 1 other identifier: XY3-PTH1708A01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• the concentration of nifedipine

  the concentration of nifedipine

  at 5-7days

Secondary Outcomes (1)

• 24-hour ambulatory blood pressure

  at 1 day and 7day

Study Arms (2)

XBDP1-

Drug: Nifedipine controlled released tablets

XBDP2-

Drug: Nifedipine controlled released tablets

Interventions

Nifedipine controlled released tablets DRUG

lower blood pressure

XBDP1-; XBDP2-

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic renal function associated with hypertension

You may qualify if:

• 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.

You may not qualify if:

• Patients with CKD requiring dialysis treatment;

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University , , China,

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang GuoPing, doctor

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Guoping, doctor

CONTACT

0086 0731 88618326; ygp9880@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: October 3, 2018
• Study Start: October 2, 2019
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)