Clinical Study on the Effect of PTH on CYP3A4 Activity | NCT03695107

Studies
Clinical Study on the Effect of PTH on CYP3A4 Activity

NCT03695107

Sponsor

The Third Xiangya Hospital of Central South University

Status

Unknown status

Last Update Posted

Sep 19, 2019Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Chronic Kidney Diseases

Interventions

Nifedipine controlled released tablets

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2, 2019Estimated

Primary Completion Date

Sep 10, 2020Estimated

Completion Date

Sep 10, 2020Estimated

First Submitted Date

Sep 17, 2018

First Submission Date that Met QC Criteria

Oct 2, 2018

First Posted Date

Oct 3, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2019

Last Update Posted Date

Sep 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
XBDP1-			Drug: Nifedipine controlled released tablets
XBDP2-			Drug: Nifedipine controlled released tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nifedipine controlled released tablets	Drug	lower blood pressure	XBDP1- XBDP2-

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Chronic renal function associated with hypertension

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yang Guoping, doctor	Contact	0086 0731 88618326		ygp9880@126.com

Overall Officials

Name	Affiliation	Role
Yang GuoPing, doctor	The Third Xiangya Hospital of Central South University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Third Xiangya Hospital of Central South University , , China,	Recruiting	Changsha	Hunan	410013	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided