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Immunosuppressant

Once vs Twice Daily Immunosuppression for Kidney Complications

Phase 4
Recruiting
Led By Rowena Delos Santos
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >/= 18 years old
Kidney transplant recipient
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 12 months post transplant
Awards & highlights

Study Summary

This trial will compare two different immunosuppressive drug regimens to see which is better in terms of compliance, tolerability, and effectiveness.

Who is the study for?
This trial is for adults over 18 who have received a kidney transplant and were treated with Thymoglobulin. It's not suitable for those who've had non-kidney organ transplants, can't take Envarsus post-transplant, or were discharged to an acute care facility after their transplant.Check my eligibility
What is being tested?
The study compares two immunosuppression regimens in kidney transplant recipients: one group will take Envarsus/azathioprine once daily, while the other will take tacrolimus/mycophenolic acid twice daily. The goal is to see which regimen leads to better compliance and fewer rejections.See study design
What are the potential side effects?
Potential side effects may include issues related to immune system suppression such as increased risk of infections, possible drug-specific reactions like gastrointestinal discomfort or liver enzyme changes, and potential medication-related toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have received a kidney transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 12 months post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 12 months post transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Compliance and tolerability of medication regimen at 3 and 12 months
Secondary outcome measures
Change in Self-recorded Compliance and tolerability of medication regimen at 3 and 12 months
Composite endpoint measurement

Trial Design

2Treatment groups
Active Control
Group I: Once daily regimenActive Control1 Intervention
Once daily medication regimen (Envarsus and azathioprine)
Group II: Twice daily regimenActive Control1 Intervention
Twice daily medication regimen (Tacrolimus and mycophenolic acid)

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,625 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,066 Total Patients Enrolled
Rowena Delos SantosPrincipal InvestigatorWashington University School of Medicine

Media Library

Azathioprine (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT03555448 — Phase 4
Kidney Complication Research Study Groups: Once daily regimen, Twice daily regimen
Kidney Complication Clinical Trial 2023: Azathioprine Highlights & Side Effects. Trial Name: NCT03555448 — Phase 4
Azathioprine (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03555448 — Phase 4
~5 spots leftby Dec 2024
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