Standard Therapy or Individualized Immunosuppression For... | NCT04473924

Studies
Standard Therapy or Individualized Immunosuppression For Lowering Adverse Event Risk

NCT04473924

Sponsor

University of California, San Francisco

Status

Withdrawn

Last Update Posted

May 6, 2022Actual

Enrollment

0Actual

Phase

Phase 2

Conditions

Infection
Transplant;Failure,Kidney

Interventions

Mycophenolate Mofetil
Mycophenolate Mofetil

Countries

United States

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

May 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study has never started as sponsor did not approve for funding.

Expanded Access Info

Start Date

Jul 2022Estimated

Primary Completion Date

Jan 2023Estimated

Completion Date

May 2023Estimated

First Submitted Date

Jul 13, 2020

First Submission Date that Met QC Criteria

Jul 13, 2020

First Posted Date

Jul 16, 2020Actual

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

May 2, 2022

Last Update Posted Date

May 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Infections are common and associated with poor outcomes as well as high financial costs after kidney transplantation. Identifying and implementing strategies to reduce infections after kidney transplantation is important for improving patient outcomes. This study seeks to determine the feasibility of body surface area-based dosing of mycophenolate compared to standard dosing of mycophenolate in a pilot randomized controlled trial.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Body surface area-based mycophenolate dosing	Experimental	Intervention group will receive mycophenolate mofetil 750 mg/m^2/day divided into twice daily dosing.	Drug: Mycophenolate Mofetil
Standard (fixed) dosing	Active Comparator	Active comparator group will receive standard fixed dosing of mycophenolate mofetil 1000 mg twice daily.	Drug: Mycophenolate Mofetil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mycophenolate Mofetil	Drug	Body surface area-based dosing of mycophenolate	Body surface area-based mycophenolate dosing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Enrollment rate in a trial of BSA-based vs. fixed dosing of mycophenolate	Assess the ratio of participants screened to enrolled into the study	6 months

Secondary Outcomes

Measure	Description	Time Frame
Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate	Assess the rate of dropout from the study	6 months
Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult transplant recipients ≥18 years of age who have a functional allograft and have undergone kidney transplantation between six months and two years prior to study enrollment
Receiving mycophenolate mofetil for maintenance transplant immunosuppression at the time of the screening visit

Exclusion Criteria:

Evidence of rejection on routine six month post-transplant biopsy
Prior intolerance to mycophenolate mofetil necessitating drug discontinuation
Are or are planning to become pregnant, due to inability to take mycophenolate
Are marginally housed, due to concerns regarding routine follow-up
Are actively participating in a different interventional trial that may affect immunosuppression dosing
Are unwilling to consent to participate
Institutionalized individuals or prisoners
Are actively abusing illicit drugs or alcohol
Have a history of poor or doubtful compliance (e.g., frequently missed appointments)
Have cognitive impairment prohibiting participation in the study

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elaine Ku, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94143	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007239	Infections

Intervention Browse Module

MeSH Terms

ID	Term
D009173	Mycophenolic Acid

Ancestor Terms

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided