Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04473924
Other study ID # 20-31500
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date July 2022
Est. completion date May 2023

Study information

Verified date May 2022
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2023
Est. primary completion date January 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Mycophenolate Mofetil
Body surface area-based dosing of mycophenolate
Mycophenolate Mofetil
Standard (fixed) dosing of mycophenolate

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Feasibility of a trial of BSA-based vs. fixed dosing of mycophenolate Assess the rate of dropout from the study 6 months
Secondary Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate Collect pilot data on number of overall hospitalizations 6 months
Secondary Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate Collect pilot data on infectious-related hospitalizations 6 months
Secondary Collect pilot data of efficacy in a trial of BSA-based vs. fixed dosing of mycophenolate Collect pilot data on incidence of leukopenia 6 months
See also
  Status Clinical Trial Phase
Completed NCT04529421 - Assocation Between In-person Instruction and COVID-19 Risk
Recruiting NCT04081792 - Optimal Antibiotics for Operated Diabetic Foot Infections N/A
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Recruiting NCT00342589 - New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Completed NCT03296423 - Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly Phase 4
Withdrawn NCT04217252 - Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection N/A
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Recruiting NCT02905552 - Myelodysplasic Syndromes and Risk Factors for Infection N/A
Withdrawn NCT02904434 - Gastrointestinal Implications of Voriconazole Exposure
Active, not recruiting NCT02768454 - Antimicrobials Stewardship by Pharmacist N/A
Completed NCT02219776 - Decreasing Infection In Arthroscopic Shoulder Surgery N/A
Completed NCT02210169 - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates N/A
Recruiting NCT02098226 - Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts N/A
Completed NCT01846832 - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection Phase 3
Terminated NCT01441206 - Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants Phase 1
Completed NCT01434797 - Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
Completed NCT01159834 - Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital) N/A