NCT03083769

Brief Summary

The purpose of this study is to determine whether functional genetic variants can affect tacrolimus dose corrected trough levels and associate with the side effects in Chinese renal transplant recipients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1998

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
19.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 20, 2019

Completed
Last Updated

November 20, 2019

Status Verified

October 1, 2019

Enrollment Period

21.6 years

First QC Date

March 8, 2017

Results QC Date

October 12, 2019

Last Update Submit

October 31, 2019

Conditions

Transplantation

Keywords

tacrolimusgenetic variantsside effects

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Acute Rejection

    We will measure the number of participants with acute rejection during the day 1 to day 61 after transplantation. Kaplan-Meier analyses were performed for acute rejection in participants with different genotypes.

    Day 1 to Day 61

  • Number of Participants With Tacrolimus-related Nephrotoxicities

    We will measure the number of participants with tacrolimus-related nephrotoxicities during the day 1 to day 61 after transplantation. Kaplan-Meier analyses were performed for tacrolimus-related nephrotoxicities in participants with different genotypes.

    Day1 to Day 61

  • Number of Participants With Tacrolimus-related Neurotoxicities

    We will measure the number of participants with tacrolimus-related neurotoxicities during the day 1 to day 61 after transplantation. Kaplan-Meier analyses were performed for tacrolimus-related neurotoxicities in participants with different genotypes.

    Day1 to Day 61

Study Arms (2)

Cohort 1

The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.

Cohort 2

The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population consists of the renal transplant recipients who received tacrolimus as immunosuppressant from Nanfang Hospital and Guilin No.924 Hospital. All the patients are Chinese.

You may qualify if:

  • Subject has been conducted kidney transplantation. Subject has used tacrolimus as immunosuppressant.

You may not qualify if:

  • Simultaneous liver-kidney transplantation. Patients with age less than 18 years old. Tacrolimus blood concentration monitoring less than 3 times. Failed to extract DNA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

Guilin No.924 Hospital

Guilin, Guangxi, 541002, China

Location

Related Publications (2)

  • Maseko N, Yang S, Li C, Zhang S, Wang R, Zhang Y, Li C, Zhang C, Li L. Impact of genetic polymorphisms on tacrolimus trough blood concentration in Chinese liver transplant recipients. Pharmacogenomics. 2023 Mar;24(4):207-217. doi: 10.2217/pgs-2022-0180. Epub 2023 Mar 17.

    PMID: 36927114DERIVED

  • Yang S, Jiang H, Li C, Lu H, Li C, Ye D, Qi H, Xu W, Bao X, Maseko N, Zhang S, Shao R, Li L. Genomewide association study identifies a novel variant associated with tacrolimus trough concentration in Chinese renal transplant recipients. Clin Transl Sci. 2022 Nov;15(11):2640-2651. doi: 10.1111/cts.13388. Epub 2022 Aug 28.

    PMID: 35977080DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Human genomic DNA was extracted from leukocytes in patients' peripheral blood.

Results Point of Contact

Title
Dr. Liang Li
Organization
Southern Medical University
liliang@smu.edu.cn
86 20 61648510

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 20, 2017

Study Start

January 1, 1998

Primary Completion

July 30, 2019

Study Completion

August 1, 2019

Last Updated

November 20, 2019

Results First Posted

November 20, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)