NCT03794817

Brief Summary

The purpose of this study is to test the effect of anti-rejection medications on your immune system

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

August 20, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
Last Updated

January 7, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

December 12, 2018

Last Update Submit

January 3, 2019

Conditions

Kidney Failure

Keywords

Kidney transplant recipient

Outcome Measures

Primary Outcomes (1)

  • Immune monitoring in sensitized patients at risk of rejection

    Pretransplant Kidney Solid Organ Response Test (kSORT) predictive value of rejection in the first 6 months after transplantation

    2 years

Secondary Outcomes (1)

  • Kidney Solid Organ Response Test (kSORT) with pathological findings

    2 years

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have received a kidney transplant and will be taking immunosuppressive medications.

You may qualify if:

  • years or older able to consent
  • No history of HIV, hepatitis C and active hepatitis B infection
  • cPRA ≥ 50%

You may not qualify if:

  • Patients on Coumadin
  • Human Leukocyte antigen (HLA) identical donor recipient patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Flavio Vincenti, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

January 7, 2019

Study Start

August 20, 2015

Primary Completion

September 8, 2017

Study Completion

September 8, 2017

Last Updated

January 7, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)