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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 belowSelect...
I am 18 years old or older.
Select...
I have received a kidney transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months and 12 months post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 12 months post transplant
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)
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,727 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was moved to a specialized care facility after my transplant.I have received Thymoglobulin induction therapy.I cannot take Envarsus after my transplant.I have had an organ transplant that is not a kidney.I am 18 years old or older.I have had a combined organ transplant.I have received a kidney transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Once daily regimen
- Group 2: Twice daily regimen
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration sanctioned a regimen of single daily doses?
"The safety of a daily regimen is rated highly at 3, as this treatment has already received regulatory approval."
Answered by AI
Are there opportunities to enroll in this experiment currently?
"This research endeavour is actively recruiting participants. According to the protocol posted on clinicaltrials.gov, which was last revised in November 2021, it was initially announced in June 2018."
Answered by AI
What is the total enrollment capacity for this research endeavor?
"Affirmative. Clinical trials website highlights that the trial, first posted on June 4th 2018, is currently recruiting patients. One hundred participants are being sought at a single medical facility."
Answered by AI
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