Clinical Study on the Effect of PTH on CYP3A4 Activity

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

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: Nifedipine controlled released tablets

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • The Third Xiangya Hospital of Central South University , , China,
      • Contact: Yang Guoping, professor, doctor; Phone Number: 0086 0731 88618326; Email: ygp9880@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chronic renal function associated with hypertension

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
XBDP1-	Drug: Nifedipine controlled released tablets; lower blood pressure
XBDP2-	Drug: Nifedipine controlled released tablets; lower blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the concentration of nifedipine	the concentration of nifedipine	at 5-7days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour ambulatory blood pressure	mean blood pressure	at 1 day and 7day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): October 2, 2019
• Primary Completion (Anticipated): September 10, 2020
• Study Completion (Anticipated): September 10, 2020

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Nifedipine
• Other Study ID Numbers: XY3-PTH1708A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No