ImmunosuppressionPhase 4TaC:DropNCT06268769
Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs
A Phase 4 study testing Tacrolimus Pill and Tacrolimus capsule in people with Immunosuppression, run by Edward Geissler at 13 sites in Germany.
Trial summary
The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunosuppression
- What is being tested?
- Tacrolimus Pill and Tacrolimus capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 13 sitesGermany
- Study dates
- 9 Mar 2024to Nov 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Signed and dated written informed consent
- Adult (≥18 years old) male or female
- Renal insufficiency necessitating kidney transplantation and approved to receive a first or second kidney allograft from a living or deceased organ donor
- ABO blood type compatible with the donor kidney
- Able to swallow an oral formulation of tacrolimus in tablet or capsule form
Who cannot join
- Multi-organ transplantation
- Any previous solid organ transplantation (other than a first kidney allograft)
- For recipients of a second kidney transplant: loss of first kidney transplant within 2 years after transplantation owing to immunological reasons or recurrence of the underlying renal disease
- Patient and/or donor is positive for active HCV, HBV or HIV infection
- History of any malignancy that could not be curatively treated
- Ongoing abuse of drugs or alcohol
Show all 16Show fewer
- Signs of advanced liver disease or any signs of liver decompensation
- Ongoing uncontrolled systemic infection
- Severe diarrhoea, vomiting, active peptic ulcer, previous bariatric surgery, or any other gastrointestinal disorder that may affect absorption of tacrolimus
- Planned or foreseeable use of cyclosporine, belatacept or any tacrolimus preparation other than Envarsus® or Advagraf™
- Known contraindication or hypersensitivity to tacrolimus, and/or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC) of both Envarsus® and Advagraf™, and/or to any other macrolides
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless using a highly-effective method of contraception
- Participation in another interventional clinical trial in the time period starting from 4 weeks prior to randomisation and throughout the entire trial period
- Any condition or factor which, in the judgement of the investigator, would place the subject at undue risk, invalidate communication with the investigator or study team, or hamper compliance with the trial protocol or follow-up schedule
- Inability to freely give informed consent (e.g. individuals under legal guardianship)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
University Hospital Aachen, Department of General, Visceral and Transplant Surgery
Aachen, 52074
Charité Universitätsmedizin, Department of Nephrology and Medical Intensive Care
Berlin, 10117
Knappschaft Clinic, University Hospital Bochum, Department of Surgery
Bochum, 44892
University Hospital Dresden, Division of Nephrology
Dresden, 01307
University Medical Center Hamburg-Eppendorf, Internal Medicine III (Nephrology, Rheumatology, Endocrinology)
Hamburg, 20251
Hannover Medical School, Department of General, Visceral and Transplant Surgery
Hanover, 30625
University Hospital Jena, Internal Medicine III, Nephrology
Jena, 07747
University Medical Center of the Johannes Gutenberg University Mainz, Medical Clinic I. (Nephrology)
Mainz, 55131
University Hospital Mannheim, Medical Clinic V
Mannheim, 68167
LMU University Hospital Munich, Department of General, Visceral and Transplant Surgery
Munich, 81377
University Hospital Münster, Medical Clinic D
Münster, 48149
University Hospital Regensburg, Department of Nephrology
Regensburg, 93053
University Hospital Würzburg, Medical Clinic I, Department of Nephrology
Würzburg, 97080
About this study
Official title: Multicentre, Open-label, Randomised, Two-arm, Parallel-group, Superiority Trial to Assess Bioavailability and Practicability of Two Once-daily Tacrolimus Formulations, Envarsus® Compared With Advagraf™, Administered in Kidney Transplant Recipients
The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit.
Read the detailed description
This clinical trial aims to compare the bioavailability and practicability of two alternative once-daily formulations of tacrolimus in patients who have received either a first or second kidney transplant and require prophylactic immunosuppressive treatment to prevent allograft rejection. Trial participants are randomised within 7 days prior to kidney transplantation surgery in a 1:1 ratio to two alternative treatment arms containing either Envarsus (test arm) or Advagraf (comparator arm) as first-line calcineurin inhibitor within a standard-of-care immunosuppressive regimen. Tacrolimus blood trough levels and drug doses are monitored at regular intervals to measure a dose-normalised trough level (concentration/dose, C/D ratio) as an estimate of tacrolimus bioavailability.
The primary objective is to demonstrate that the C/D ratio of tacrolimus measured in kidney transplant recipients treated with Envarsus® (test drug) is superior to (higher than) the C/D ratio measured in patients treated with Advagraf™ (comparator drug) at 12 weeks post-transplantation. The trial also aims to compare the practicability (handling) of these two once-daily drug formulations using a series of pharmacokinetic parameters that will measure the speed with which therapeutic blood trough levels are attained and the ease with which stable blood trough levels are maintained over time.
Secondarily, TaC:Drop aims to explore the relationship between the early C/D ratio measured at 12 weeks post-transplantation and later clinical outcomes measured until three years post-transplantation. The study aims to investigate whether a superior pharmacokinetic drug profile is associated with fewer and milder dose-dependent drug toxicities and superior kidney graft function, as measured by long-term safety and efficacy parameters.
Drug pharmacokinetics will be explored in greater detail during a sub-study designed to profile the peak blood concentration of Envarsus® and Advagraf™ at 12 weeks post-transplantation in patients who volunteer to provide three additional blood samples at two-hour intervals after drug intake on the day of the 12-week trial visit. Participation in this sub-study is voluntary and available to all trial centres and all trial patients.
- Conditions
- Immunosuppression
- Being tested
- Tacrolimus Pill, Tacrolimus capsule
- Keywords
- Kidney transplantation, Tacrolimus, Concentration/dose ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus PillDrug
Also called Envarsus
Envarsus tablets dosed to achieve and maintain whole blood trough levels of tacrolimus within a therapeutic range of 5-12 ng/ml during the first 4 weeks post-transplantation, and 5-8 ng/ml thereafter.
Tacrolimus capsuleDrug
Also called Advagraf
Advagraf capsules dosed to achieve and maintain whole blood trough levels of tacrolimus within a therapeutic range of 5-12 ng/ml during the first 4 weeks post-transplantation, and 5-8 ng/ml thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Envarsus | Experimental | Participants take prolonged-release tacrolimus tablets (Envarsus) orally once daily and additionally receive standard-of-care immunosuppressive background therapy according to routine practice. Receives: Drug: Tacrolimus Pill |
| Advagraf | Active comparator | Participants take prolonged-release tacrolimus capsules (Advagraf) orally once daily and additionally receive standard-of-care immunosuppressive background therapy according to routine practice. Receives: Drug: Tacrolimus capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-normalised blood trough level of tacrolimus (concentration/dose ratio)
To calculate C/D ratio, "concentration" is the blood trough level of tacrolimus measured in a blood sample collected immediately prior to drug dosing on the day of the 12-week trial visit and "dose" is the daily dose taken by the patient on the day prior to the visit. C/D ratio is measured as a surrogate for tacrolimus bioavailability (i.e. systemic exposure per mg of drug). The primary endpoint uses a blood trough level reading that is measured in a central laboratory.
Measured: 12 weeks after kidney transplantation
Secondary outcomes (31)
Time to reach the first trough level in target range
Reaching the target range is defined as two consecutive readings within the initial target range of 5-12 ng/ml; time is measured to the date of the first in-range reading
Measured: Time period measured in days, assessed within the first 2 weeks after kidney transplantation
Proportion of patients with trough levels lower, within, or higher than the target range
Measured: 4 days, 14 days, 28 days and 12 weeks after kidney transplantation
Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels
Measured: 4 days, 14 days, 28 days and 12 weeks after kidney transplantation
Mean daily dose of tacrolimus and inter-patient variability (range) of tacrolimus daily dose
Measured: 4 days, 14 days, 28 days and 12 weeks after kidney transplantation
Tacrolimus concentration/dose (C/D) ratio
The secondary endpoint using C/D ratio data takes a blood trough level reading that is measured in the local laboratory at the trial site.
Measured: 4 days, 14 days, 28 days and 1, 2, 3 years after kidney transplantation
Intra-patient variability of C/D ratio and daily dose
Measured: Measured over the time points: day 4, day 14, day 28 and week 12
Treatment failure rate
A composite endpoint of biopsy-proven acute rejection, graft failure (defined as initiation of renal dialysis or re-transplantation), or death (from any cause)
Measured: 12 weeks and 1, 2, 3 years after kidney transplantation
Time to treatment failure after transplantation
Treatment failure is a composite endpoint of biopsy-proven acute rejection, graft failure (defined as initiation of renal dialysis or pre-emptive re-transplantation), or death (from any cause)
Measured: Measured until 3 years after kidney transplantation
Incidence rate, severity and time to clinically-confirmed biopsy-proven acute rejection
Clinically-confirmed biopsy-proven acute rejection requires both a clinical diagnosis of rejection by an investigator and a histopathological diagnosis of rejection in a for-cause biopsy. Subclinical rejection diagnosed in a protocol biopsy is therefore excluded from this definition.
Measured: 12 weeks and 1, 2, 3 years after kidney transplantation
Incidence rate of graft failure
Graft failure is defined as initiation of renal dialysis or pre-emptive re-transplantation
Measured: 12 weeks and 1, 2, 3 years after kidney transplantation
Mortality rate
Mortality rate measures death from any cause
Measured: 12 weeks and 1, 2, 3 years after kidney transplantation
Graft function measured by eGFR (estimated glomerular filtration rate)
eGFR calculated according to the CKD-EPI formula
Measured: 4 days, 14 days, 28 days, 12 weeks and 1, 2, 3 years after kidney transplantation
Incidence rate of for-cause biopsies
Measured: 12 weeks after kidney transplantation
Incidence rate of acute rejection episodes requiring treatment
Measured: 12 weeks after kidney transplantation
Incidence rate of steroid-resistant episodes of biopsy-proven acute rejection
Measured: 12 weeks and 1 year after kidney transplantation
Incidence rate of delayed graft function
Delayed graft function is defined as the need for more than one episode of dialysis after transplantation
Measured: Measurable within the first 2 weeks after kidney transplantation
Incidence rate of primary non-function of the renal allograft
Primary non-function is defined as the necessity for ongoing chronic dialysis
Measured: Measurable within the first 12 weeks after kidney transplantation
Incidence of hepatotoxicity
Hepatotoxicity is defined as GPT or GOT levels ≥ 2.5 x upper limit of normal range
Measured: 12 weeks and 1, 2, 3 years after kidney transplantation
Incidence of CMV and BKV infection (including organ manifestation, if relevant)
Measured: 12 weeks and 1 year after kidney transplantation
Incidence, type, severity and seriousness of adverse reactions (ARs)
Measured: 12 weeks and 3 years after kidney transplantation
Blood pressure
Measured: 12 weeks and 1, 2, 3 years after kidney transplantation
Incidence of de novo tremor
Incidence and severity of tremor based on medical assessment by the investigator
Measured: 12 weeks and 3 years after kidney transplantation
Incidence of gastrointestinal disorders requiring diagnostic investigation
Measured: 12 weeks and 3 years after kidney transplantation
Incidence of new onset diabetes mellitus after transplantation (NODAT)
NODAT is defined as HbA1c ≥ 6.5% or 47.5 mmol/mol or fasting plasma glucose ≥ 126 mg/dl on two separate occasions
Measured: 12 weeks and 1, 2, 3 years after kidney transplantation
Recurrence of primary kidney disease
Measured: 12 weeks and 3 years after kidney transplantation
Incidence of de novo DSA
Measured: Detected within the first year after kidney transplantation
Patient-reported health-related quality-of-life measured using the Kidney Transplant Questionnaire-34 (KTQ-34)
The KTQ-34 is a renal transplantation-specific instrument that measures quality-of-life in five dimensions. It is a self-administered questionnaire that is completed in writing by the trial patients.
Measured: 12 weeks and 3 years after kidney transplantation
Doses and duration of glucocorticosteroid treatment
Measured: 12 weeks and 1, 2, 3 years after kidney transplantation
Dose of mycophenolate
Including both mycophenolate mofetil and mycophenolic acid
Measured: 12 weeks and 1, 2, 3 years after kidney transplantation
Incidence and time to study treatment discontinuation
Measured: 3 years after kidney transplantation
Incidence, time to and reason for patient withdrawal from study
Measured: 3 years after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start9 Mar 2024
- Primary completion4 Feb 2026
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A dynamic allocation technique assigns participants in a 1:1 ratio to one of two treatment arms: Envarsus tablets (test IMP) or Advagraf capsules (comparator IMP). Randomisation is stratified by two factors: a) trial site, in order to minimise systematic treatment bias at the level of the trial centre and reduce the influence of inter-centre variability, and b) participation in the optional pharmacokinetic sub-study, in order to ensure an equal representation of Envarsus- and Advagraf-treated patients in the sub-study.
- Masking
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Geissler
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi Pharmaceuticals GmbH
- Responsible party
- Sponsor-investigator, Edward Geissler, University of Regensburg
- Investigators
- Bernhard Banas, MD, Principal investigator, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268769
- Sponsor's protocol ID
- TaC:Drop
- Other IDs
- 2023-503531-18-00, 2023
- Acronym
- TaC:Drop
- Status last verified
- Nov 2026
- First submitted
- 12 Feb 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Open-label, Randomised, Two-arm, Parallel-group, Superiority Trial to Assess Bioavailability and Practicability of Two Once-daily Tacrolimus Formulations, Envarsus® Compared With Advagraf™, Administered in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT06268769
- Acronym / sponsor ID
- TaC:Drop / TaC:Drop
- Conditions
- Immunosuppression
- Keywords
- Kidney transplantation, Tacrolimus, Concentration/dose ratio
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Edward GeisslerUniversity, hospital or other
- Collaborators
- Chiesi Pharmaceuticals GmbH
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- Nov 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit.
Detailed description
This clinical trial aims to compare the bioavailability and practicability of two alternative once-daily formulations of tacrolimus in patients who have received either a first or second kidney transplant and require prophylactic immunosuppressive treatment to prevent allograft rejection. Trial participants are randomised within 7 days prior to kidney transplantation surgery in a 1:1 ratio to two alternative treatment arms containing either Envarsus (test arm) or Advagraf (comparator arm) as first-line calcineurin inhibitor within a standard-of-care immunosuppressive regimen. Tacrolimus blood trough levels and drug doses are monitored at regular intervals to measure a dose-normalised trough level (concentration/dose, C/D ratio) as an estimate of tacrolimus bioavailability.
The primary objective is to demonstrate that the C/D ratio of tacrolimus measured in kidney transplant recipients treated with Envarsus® (test drug) is superior to (higher than) the C/D ratio measured in patients treated with Advagraf™ (comparator drug) at 12 weeks post-transplantation. The trial also aims to compare the practicability (handling) of these two once-daily drug formulations using a series of pharmacokinetic parameters that will measure the speed with which therapeutic blood trough levels are attained and the ease with which stable blood trough levels are maintained over time.
Secondarily, TaC:Drop aims to explore the relationship between the early C/D ratio measured at 12 weeks post-transplantation and later clinical outcomes measured until three years post-transplantation. The study aims to investigate whether a superior pharmacokinetic drug profile is associated with fewer and milder dose-dependent drug toxicities and superior kidney graft function, as measured by long-term safety and efficacy parameters.
Drug pharmacokinetics will be explored in greater detail during a sub-study designed to profile the peak blood concentration of Envarsus® and Advagraf™ at 12 weeks post-transplantation in patients who volunteer to provide three additional blood samples at two-hour intervals after drug intake on the day of the 12-week trial visit. Participation in this sub-study is voluntary and available to all trial centres and all trial patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A dynamic allocation technique assigns participants in a 1:1 ratio to one of two treatment arms: Envarsus tablets (test IMP) or Advagraf capsules (comparator IMP). Randomisation is stratified by two factors: a) trial site, in order to minimise systematic treatment bias at the level of the trial centre and reduce the influence of inter-centre variability, and b) participation in the optional pharmacokinetic sub-study, in order to ensure an equal representation of Envarsus- and Advagraf-treated patients in the sub-study.
| Arm | Type | Receives |
|---|---|---|
| Envarsus | Experimental | Drug: Tacrolimus PillParticipants take prolonged-release tacrolimus tablets (Envarsus) orally once daily and additionally receive standard-of-care immunosuppressive background therapy according to routine practice. |
| Advagraf | Active comparator | Drug: Tacrolimus capsuleParticipants take prolonged-release tacrolimus capsules (Advagraf) orally once daily and additionally receive standard-of-care immunosuppressive background therapy according to routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed and dated written informed consent
- Adult (≥18 years old) male or female
- Renal insufficiency necessitating kidney transplantation and approved to receive a first or second kidney allograft from a living or deceased organ donor
- ABO blood type compatible with the donor kidney
- Able to swallow an oral formulation of tacrolimus in tablet or capsule form
Key exclusion criteria (16 listed)
- Multi-organ transplantation
- Any previous solid organ transplantation (other than a first kidney allograft)
- For recipients of a second kidney transplant: loss of first kidney transplant within 2 years after transplantation owing to immunological reasons or recurrence of the underlying renal disease
- Patient and/or donor is positive for active HCV, HBV or HIV infection
- History of any malignancy that could not be curatively treated
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 |
|---|---|---|
| Tacrolimus PillAlso: EnvarsusEnvarsus tablets dosed to achieve and maintain whole blood trough levels of tacrolimus within a therapeutic range of 5-12 ng/ml during the first 4 weeks post-transplantation, and 5-8 ng/ml thereafter. | Drug | Envarsus |
| Tacrolimus capsuleAlso: AdvagrafAdvagraf capsules dosed to achieve and maintain whole blood trough levels of tacrolimus within a therapeutic range of 5-12 ng/ml during the first 4 weeks post-transplantation, and 5-8 ng/ml thereafter. | Drug | Advagraf |
Primary outcome
Dose-normalised blood trough level of tacrolimus (concentration/dose ratio)
Time frame: 12 weeks after kidney transplantation
To calculate C/D ratio, "concentration" is the blood trough level of tacrolimus measured in a blood sample collected immediately prior to drug dosing on the day of the 12-week trial visit and "dose" is the daily dose taken by the patient on the day prior to the visit. C/D ratio is measured as a surrogate for tacrolimus bioavailability (i.e. systemic exposure per mg of drug). The primary endpoint uses a blood trough level reading that is measured in a central laboratory.
31 secondary outcomes
Time to reach the first trough level in target range
Time frame: Time period measured in days, assessed within the first 2 weeks after kidney transplantation
Proportion of patients with trough levels lower, within, or higher than the target range
Time frame: 4 days, 14 days, 28 days and 12 weeks after kidney transplantation
Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels
Time frame: 4 days, 14 days, 28 days and 12 weeks after kidney transplantation
Mean daily dose of tacrolimus and inter-patient variability (range) of tacrolimus daily dose
Time frame: 4 days, 14 days, 28 days and 12 weeks after kidney transplantation
Tacrolimus concentration/dose (C/D) ratio
Time frame: 4 days, 14 days, 28 days and 1, 2, 3 years after kidney transplantation
Intra-patient variability of C/D ratio and daily dose
Time frame: Measured over the time points: day 4, day 14, day 28 and week 12
Treatment failure rate
Time frame: 12 weeks and 1, 2, 3 years after kidney transplantation
Time to treatment failure after transplantation
Time frame: Measured until 3 years after kidney transplantation
Incidence rate, severity and time to clinically-confirmed biopsy-proven acute rejection
Time frame: 12 weeks and 1, 2, 3 years after kidney transplantation
Incidence rate of graft failure
Time frame: 12 weeks and 1, 2, 3 years after kidney transplantation
Mortality rate
Time frame: 12 weeks and 1, 2, 3 years after kidney transplantation
Graft function measured by eGFR (estimated glomerular filtration rate)
Time frame: 4 days, 14 days, 28 days, 12 weeks and 1, 2, 3 years after kidney transplantation
Incidence rate of for-cause biopsies
Time frame: 12 weeks after kidney transplantation
Incidence rate of acute rejection episodes requiring treatment
Time frame: 12 weeks after kidney transplantation
Incidence rate of steroid-resistant episodes of biopsy-proven acute rejection
Time frame: 12 weeks and 1 year after kidney transplantation
Incidence rate of delayed graft function
Time frame: Measurable within the first 2 weeks after kidney transplantation
Incidence rate of primary non-function of the renal allograft
Time frame: Measurable within the first 12 weeks after kidney transplantation
Incidence of hepatotoxicity
Time frame: 12 weeks and 1, 2, 3 years after kidney transplantation
Incidence of CMV and BKV infection (including organ manifestation, if relevant)
Time frame: 12 weeks and 1 year after kidney transplantation
Incidence, type, severity and seriousness of adverse reactions (ARs)
Time frame: 12 weeks and 3 years after kidney transplantation
Blood pressure
Time frame: 12 weeks and 1, 2, 3 years after kidney transplantation
Incidence of de novo tremor
Time frame: 12 weeks and 3 years after kidney transplantation
Incidence of gastrointestinal disorders requiring diagnostic investigation
Time frame: 12 weeks and 3 years after kidney transplantation
Incidence of new onset diabetes mellitus after transplantation (NODAT)
Time frame: 12 weeks and 1, 2, 3 years after kidney transplantation
Recurrence of primary kidney disease
Time frame: 12 weeks and 3 years after kidney transplantation
Incidence of de novo DSA
Time frame: Detected within the first year after kidney transplantation
Patient-reported health-related quality-of-life measured using the Kidney Transplant Questionnaire-34 (KTQ-34)
Time frame: 12 weeks and 3 years after kidney transplantation
Doses and duration of glucocorticosteroid treatment
Time frame: 12 weeks and 1, 2, 3 years after kidney transplantation
Dose of mycophenolate
Time frame: 12 weeks and 1, 2, 3 years after kidney transplantation
Incidence and time to study treatment discontinuation
Time frame: 3 years after kidney transplantation
Incidence, time to and reason for patient withdrawal from study
Time frame: 3 years after kidney transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Bernhard Banas, MD principal investigator
University Hospital Regensburg
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus Pill and Tacrolimus capsule in people with Immunosuppression, run by Edward Geissler at 13 sites in Germany.
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 5 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Dose-normalised blood trough level of tacrolimus (concentration/dose ratio) (time frame: 12 weeks after kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.