Kidney Transplant; ComplicationsPhase 4NCT03555448

Once Daily Immunosuppression Regimen

A Phase 4 study testing Once daily immunosuppression regimen and Twice daily immunosuppression regimen in people with Kidney Transplant; Complications, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this research study is to determine whether an immunosuppressive maintenance regimen of Envarsus/azathioprine compared to a tacrolimus/ mycophenolic acid regimen is associated with better compliance, tolerability, and lower biopsy proven rejection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Transplant; Complications
What is being tested?: Once daily immunosuppression regimen and Twice daily immunosuppression regimen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 4 Jun 2018to 10 Nov 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age >/= 18 years old
Kidney transplant recipient
Thymoglobulin induction

Who cannot join

Non-renal organ transplant
Combined organ transplant
Inability to receive Envarsus after transplant
Discharged to acute care facility after transplant

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Once a Day Immunosuppression Regimen: Outcomes and Compliance

Conditions: Kidney Transplant; Complications
Being tested: Once daily immunosuppression regimen, Twice daily immunosuppression regimen
Keywords: Immunosuppression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Once daily immunosuppression regimenDrug
Intervention focuses on the type of regimen, in this case the intervention arm will receive a once daily regimen for immunosuppression compared to the twice daily regimen.
Twice daily immunosuppression regimenDrug
This is the arm which we are designating the standard, which will be the comparison to the active drug arm.

Study groups in NCT03555448
Study group	Role	What they receive
Once daily regimen	Active comparator	Once daily medication regimen (Envarsus and azathioprine) Receives: Drug: Once daily immunosuppression regimen
Twice daily regimen	Active comparator	Twice daily medication regimen (Tacrolimus and mycophenolic acid) Receives: Drug: Twice daily immunosuppression regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months
BAASIS Survey
Measured: 3 months and 12 months post transplant

Secondary outcomes (2)

Change in Self-recorded Compliance and Tolerability of Medication Regimen at 3 and 12 Months
Pill Manager (personal medication record keeping for those who participants who choose to use this method of recording their self-administered medication)
Measured: 3 months and 12 months post transplant
Composite Endpoint Measurement
Number of Participants with Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jun 201810 Nov 2023

First posted13 Jun 2018
Study start4 Jun 2018
Primary completion10 Nov 2023
Study completion10 Nov 2023

Why it stopped: poor recruitment during pandemic and after

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Kidney Transplant; ComplicationsStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03555448
Sponsor's protocol ID: 201803162
Status last verified: Dec 2024
First submitted: 17 May 2018
Last updated: 22 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Budde K, Bunnapradist S, Grinyo JM, Ciechanowski K, Denny JE, Silva HT, Rostaing L; Envarsus study group. Novel once-daily extended-release tacrolimus (LCPT) versus twice-daily tacrolimus in de novo kidney transplants: one-year results of Phase III, double-blind, randomized trial. Am J Transplant. 2014 Dec;14(12):2796-806. doi: 10.1111/ajt.12955. Epub 2014 Oct 2.
PubMed 25278376
Bunnapradist S, Ciechanowski K, West-Thielke P, Mulgaonkar S, Rostaing L, Vasudev B, Budde K; MELT investigators. Conversion from twice-daily tacrolimus to once-daily extended release tacrolimus (LCPT): the phase III randomized MELT trial. Am J Transplant. 2013 Mar;13(3):760-9. doi: 10.1111/ajt.12035. Epub 2012 Dec 21.
PubMed 23279614
Jamieson NJ, Hanson CS, Josephson MA, Gordon EJ, Craig JC, Halleck F, Budde K, Tong A. Motivations, Challenges, and Attitudes to Self-management in Kidney Transplant Recipients: A Systematic Review of Qualitative Studies. Am J Kidney Dis. 2016 Mar;67(3):461-78. doi: 10.1053/j.ajkd.2015.07.030. Epub 2015 Sep 11.
PubMed 26372087
Laliberte F, Nelson WW, Lefebvre P, Schein JR, Rondeau-Leclaire J, Duh MS. Impact of daily dosing frequency on adherence to chronic medications among nonvalvular atrial fibrillation patients. Adv Ther. 2012 Aug;29(8):675-90. doi: 10.1007/s12325-012-0040-x. Epub 2012 Aug 15.
PubMed 22898791
Rostaing L, Bunnapradist S, Grinyo JM, Ciechanowski K, Denny JE, Silva HT Jr, Budde K; Envarsus Study Group. Novel Once-Daily Extended-Release Tacrolimus Versus Twice-Daily Tacrolimus in De Novo Kidney Transplant Recipients: Two-Year Results of Phase 3, Double-Blind, Randomized Trial. Am J Kidney Dis. 2016 Apr;67(4):648-59. doi: 10.1053/j.ajkd.2015.10.024. Epub 2015 Dec 22.
PubMed 26717860
Vrijens B, Heidbuchel H. Non-vitamin K antagonist oral anticoagulants: considerations on once- vs. twice-daily regimens and their potential impact on medication adherence. Europace. 2015 Apr;17(4):514-23. doi: 10.1093/europace/euu311. Epub 2015 Feb 17.
PubMed 25694538

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
Kidney Transplant; Complications, Kidney Transplant Failure
RecruitingObservational study
Vascular Complications After Kidney Transplantation
Kidney Transplant Recipient, Kidney Transplant; Complications
Active, not recruitingObservational study
Australian Genomics Of Chronic Allograft Dysfunction Study
Kidney Transplant Rejection, Kidney Transplant; Complications
Enrolling by invitationObservational study
GEnomic Medicine in Kidney Transplantation Study
Transplant Complication, Kidney Transplant Rejection
RecruitingEarly Phase 1
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
Kidney Failure Chronic, Stem Cell Transplant

All Kidney Transplant; Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Once a Day Immunosuppression Regimen: Outcomes and Compliance
ClinicalTrials.gov ID: NCT03555448
Acronym / sponsor ID: 201803162
Conditions: Kidney Transplant; Complications
Keywords: Immunosuppression
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: poor recruitment during pandemic and after
Enrolment: 51 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: Veloxis Pharmaceuticals
Study start: 4 Jun 2018 (actual)
Primary completion: 10 Nov 2023 (actual)
Study completion: 10 Nov 2023 (actual)
First posted: 13 Jun 2018 (actual)
Results: Posted 22 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Once daily regimen	Active comparator	Drug: Once daily immunosuppression regimenOnce daily medication regimen (Envarsus and azathioprine)
Twice daily regimen	Active comparator	Drug: Twice daily immunosuppression regimenTwice daily medication regimen (Tacrolimus and mycophenolic acid)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age >/= 18 years old
Kidney transplant recipient
Thymoglobulin induction

Key exclusion criteria (4 listed)

Non-renal organ transplant
Combined organ transplant
Inability to receive Envarsus after transplant
Discharged to acute care facility after transplant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Once daily immunosuppression regimenIntervention focuses on the type of regimen, in this case the intervention arm will receive a once daily regimen for immunosuppression compared to the twice daily regimen.	Drug	Once daily regimen
Twice daily immunosuppression regimenThis is the arm which we are designating the standard, which will be the comparison to the active drug arm.	Drug	Twice daily regimen

Primary outcome

Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months
Time frame: 3 months and 12 months post transplant
BAASIS Survey

2 secondary outcomes

Change in Self-recorded Compliance and Tolerability of Medication Regimen at 3 and 12 Months
Time frame: 3 months and 12 months post transplant
Composite Endpoint Measurement
Time frame: 12 months

Results and safety

Results posted to the registry on 22 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Once Daily Regimen	25	23
Twice Daily Regimen	26	24

Primary outcome: Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months

Time frame: 3 months and 12 months post transplant. Number. Unit: participants

Measure	Once Daily Regimen n = 23	Twice Daily Regimen n = 24
3month:Q1 Do you recall not having taken your immunosuppressive meds some times in the past 4 weeks?	1	2
3month:Q2 Have you skipped several consecutive doses of immunosuppressive meds in the past 4 weeks?	0	0
3month:Q3 Do you recall taking immunos meds with >2hrs from the prescribed time in the past 4 weeks?	9	5
3month:Q4 Have you reduced the prescribed amount of immunosuppressive meds during the past 4 weeks?	1	0
12month:Q1 Do you recall not having taken your immunosuppressive meds some times in past 4 weeks?	1	2
12month:Q2 Have you skipped several consecutive doses of immunosuppressive meds in the past 4 weeks?	0	1
12mth:Q3 Do you recall taking immunos meds with >2hrs from the prescribed time in the past 4 weeks?	3	6
12month:Q4 Have you reduced the prescribed amount of immunosuppressive meds during the past 4 weeks?	0	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year from time of transplant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Once Daily Regimen	9 of 23 (39.1%)	1 of 23 (4.3%)	1 of 23
Twice Daily Regimen	13 of 24 (54.2%)	1 of 24 (4.2%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25278376Budde K, Bunnapradist S, Grinyo JM, Ciechanowski K, Denny JE, Silva HT, Rostaing L; Envarsus study group. Novel once-daily extended-release tacrolimus (LCPT) versus twice-daily tacrolimus in de novo kidney transplants: one-year results of Phase III, double-blind, randomized trial. Am J Transplant. 2014 Dec;14(12):2796-806. doi: 10.1111/ajt.12955. Epub 2014 Oct 2.
Background: PubMed 23279614Bunnapradist S, Ciechanowski K, West-Thielke P, Mulgaonkar S, Rostaing L, Vasudev B, Budde K; MELT investigators. Conversion from twice-daily tacrolimus to once-daily extended release tacrolimus (LCPT): the phase III randomized MELT trial. Am J Transplant. 2013 Mar;13(3):760-9. doi: 10.1111/ajt.12035. Epub 2012 Dec 21.
Background: PubMed 26372087Jamieson NJ, Hanson CS, Josephson MA, Gordon EJ, Craig JC, Halleck F, Budde K, Tong A. Motivations, Challenges, and Attitudes to Self-management in Kidney Transplant Recipients: A Systematic Review of Qualitative Studies. Am J Kidney Dis. 2016 Mar;67(3):461-78. doi: 10.1053/j.ajkd.2015.07.030. Epub 2015 Sep 11.
Background: PubMed 22898791Laliberte F, Nelson WW, Lefebvre P, Schein JR, Rondeau-Leclaire J, Duh MS. Impact of daily dosing frequency on adherence to chronic medications among nonvalvular atrial fibrillation patients. Adv Ther. 2012 Aug;29(8):675-90. doi: 10.1007/s12325-012-0040-x. Epub 2012 Aug 15.
Background: PubMed 26717860Rostaing L, Bunnapradist S, Grinyo JM, Ciechanowski K, Denny JE, Silva HT Jr, Budde K; Envarsus Study Group. Novel Once-Daily Extended-Release Tacrolimus Versus Twice-Daily Tacrolimus in De Novo Kidney Transplant Recipients: Two-Year Results of Phase 3, Double-Blind, Randomized Trial. Am J Kidney Dis. 2016 Apr;67(4):648-59. doi: 10.1053/j.ajkd.2015.10.024. Epub 2015 Dec 22.
Background: PubMed 25694538Vrijens B, Heidbuchel H. Non-vitamin K antagonist oral anticoagulants: considerations on once- vs. twice-daily regimens and their potential impact on medication adherence. Europace. 2015 Apr;17(4):514-23. doi: 10.1093/europace/euu311. Epub 2015 Feb 17.
Individual participant dataSharing planned: No

Related trials for Kidney Transplant; Complications

Active, not recruitingPhase 4
Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
Kidney Transplant; Complications, Kidney Transplant Failure
RecruitingObservational study
Vascular Complications After Kidney Transplantation
Kidney Transplant Recipient, Kidney Transplant; Complications
Active, not recruitingObservational study
Australian Genomics Of Chronic Allograft Dysfunction Study
Kidney Transplant Rejection, Kidney Transplant; Complications
Enrolling by invitationObservational study
GEnomic Medicine in Kidney Transplantation Study
Transplant Complication, Kidney Transplant Rejection
RecruitingEarly Phase 1
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
Kidney Failure Chronic, Stem Cell Transplant

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rowena Delos Santos principal investigator

Washington University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Compliance and Tolerability of Medication Regimen at 3 and 12 Months (time frame: 3 months and 12 months post transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03555448, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.