NCT05057832

Brief Summary

Observational, prospective, single-center follow-up study carried out with patients from the area of the Virgen de Macarena University Hospital, diagnosed with chronic kidney disease, who started treatment with ustekinumab.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

November 17, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

September 16, 2021

Last Update Submit

November 15, 2021

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • Determine breakpoints.

    To determine the breakpoints for ustekinumab levels between which clinical remission is expected in patients with inflammatory bowel disease.

    Up to 44 weeks.

Study Arms (1)

Cases

Patients treated with Ustekinumab.

Eligibility Criteria

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

All patients treated with ustekinumab who have had their levels measured will be included.

You may qualify if:

  • Over 18 years.
  • Patients treated with ustekinumab in induction and maintenance phase.
  • They must agree to participate in the clinical study, having previously signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen de Macarena

Seville, 41009, Spain

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Federico Arguelles Arlas

    Hospital Universitario Virgen Macarena

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Arguelles Arias

CONTACT

955 00 80 00farguelles@telefonica.net

Carlos García Pérez

CONTACT

955 04 31 27administracion.eecc.hvm.sspa@juntadeandalucia.es

Study Design

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

Study Record Dates

First Submitted

September 16, 2021

First Posted

September 27, 2021

Study Start

May 1, 2021

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

November 17, 2021

Record last verified: 2021-04

Locations

ES(1)