Renal InsufficiencyPhase 4AllegroNCT01560572
Steroid Free Immunosuppression or Calcineurin Inhibitor Minimization After Basiliximab Induction Therapy in Kidney Transplantation: Comparison With a Standard Quadruple Immunosuppressive Regimen
A Phase 4 study testing tacrolimus OD, mycophenolic acid, prednisolone in people with Renal Insufficiency and Kidney Transplantation, run by University Medical Center Groningen at 3 sites in Netherlands.
Trial summary
A prospective, open, randomized trial, in which the investigators aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency, Kidney Transplantation
- What is being tested?
- tacrolimus OD, mycophenolic acid, prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 3 sitesNetherlands
- Study dates
- Apr 2011to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- recipient of a kidney graft (first of second) from a deceased or living (non-HLA identical) donor
Who cannot join
- patients with multi-organ transplants
- patients who are receiving a third or fourth transplant
- patients who have > 75% (current of historic) panel reactive antibodies
- patients receiving a kidney from a HLA identical living donr
- female patients who are pregnant or unwilling to used adequate contraception during the study
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Academisch Medisch Centrum
Amsterdam
University Medical Center Groningen
Groningen
Leiden University Medical Center
Leiden
About this study
A prospective, open, randomized trial, in which the investigators aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies. Immunosuppression without steroids and CNI minimization is compared to standard immunosuppression, consisting of tacrolimus OD, mycophenolic acid and corticosteroids.
Read the detailed description
Before transplantation 300 patients will be randomized 1:1:1 in three groups. Group 1 will be treated with basiliximab induction and a three day course of steroids followed by a steroid free maintenance regimen consisting of standard-dose tacrolimus OD and mycophenolic acid. Group 2 will be treated with Basiliximab induction followed by standard-dose tacrolimus OD, mycophenolic acid and steroids. Group 3 will be treated with basiliximab induction followed by standard-dose tacrolimus OD for six months, whereafter the dose will be reduced plus mycophenolic acid and steroids. The total study period will be 2 years. Primary endpoint will be renal function, proteinuria and microalbuminuria measured 24 months after transplantation. Renal function will be measured by serum Creatinine, Creatinine clearances and CKD-EPI. Secondary endpoints will be the degree of tubular atrophy and interstitial fibrosis and the degree of arteriolar hyalinosis in renal biopsies taken at 12 and 24 months after transplantation. Biopsies will be evaluated according to the Banff Criteria for Renal Allograft Biopsy Interpretation. Quantitative morphometric analysis of interstitial fibrous tissue will be performed using the digital image analysis technique. Other secondary endpoints are patient and graft survival, the incidence of allograft rejection, cardiovascular accidents, pulse wave velocity, blood pressure, the number of antihypertensives, lipid profile, the incidence of malignancies, the incidence of infectious complications, the incidence of post transplant diabetes mellitus and the development of osteoporosis.
- Conditions
- Renal Insufficiency, Kidney Transplantation
- Being tested
- tacrolimus OD, mycophenolic acid, prednisolone
- Keywords
- kidney transplantation, immunosuppression, steroids, tacrolimus OD
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus OD, mycophenolic acid, prednisoloneDrug
Also called advagraf, mycophenolic acid
tacrolimus maintenance 6-10 ng/ml, in the low dose tacrolimus group after 6 months fixed dose reduction of 50% tacrolimus through levels will be 3-5 ng/ml mycophenolic acid 2 dd 720mg, after 2 weeks reduced to 2 dd 540 mg in all groups methylprednisolone 500, 250, 125 mg on day 0, 1, and 2 in all groups prednisolone 1 dd 10 mg, and from week 6 prednisolone 7.5 mg in the standard immunosuppression and low dose tacrolimus group No prednisolone will be given the steroid free group
| Study group | Role | What they receive |
|---|---|---|
| standard immunosuupression | Active comparator | triple maintenance immunosuppression with tacrolimus OD (maintenance 6-10 ng/ml), mycophenolic acid 2 dd 540mg and prednisolone 7.5 mg Receives: Drug: tacrolimus OD, mycophenolic acid, prednisolone |
| steroidfree | Experimental | maintenance immunosuppression with tacrolimus OD (target range 6-10 ng/ml), mycophenolic acid (2 dd 540 mg) Receives: Drug: tacrolimus OD, mycophenolic acid, prednisolone |
| low dose tacrolimus | Experimental | triple maintenance immunosuppression with tacrolimus OD (maintenance 6-10 ng/ml), mycophenolic acid 2 dd 540mg and prednisolone 7.5 mg. After 6 months lowering of tacrolimus OD maintenance 3-5 ng/ml Receives: Drug: tacrolimus OD, mycophenolic acid, prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function parameters
renal function as measured by serum Creatinine and Creatinine Clearance, CKD-EPI, proteinuria
Measured: 24 months
Secondary outcomes (7)
tubular atrophy and interstitial fibrosis
tubular atrophy and interstitial fibrosis in renal biopsies
Measured: 24 months
rejection episodes
number of treated biopsy proven acute rejection episodes (as scored by pathologist via Banff classification)
Measured: two years
graft and patient survival
graft and patient survival
Measured: two years
myocardial infarctions
number of myocardial infarctions
Measured: two years
cerebrovascular accidents
number of cerebrovascular accidents
Measured: two years
number of participants with infectious complications
bacterial and viral infections as measured by culture (bacterial infections) or PCR (viral infections)
Measured: two years
number of participants with osteoporosis
as established by dexa bone densitometry
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, J.S.F. Sanders, University Medical Center Groningen
- Investigators
- Jan-Stephan Sanders, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560572
- Sponsor's protocol ID
- Allegro
- Acronym
- Allegro
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2011
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jonker J, van den Born JC, Kremer D, van Sandwijk MS, Gelinck A, Meziyerh S, Moes DJAR, Smit C, Gomes-Neto AW, Hilhorst M, Vart P, Berger SP, Bakker SJL, Florquin S, de Vries APJ, Bemelman FJ, Touw DJ, Sanders JSF. Plasma versus Whole Blood Tacrolimus Concentration and Outcomes after Kidney Transplantation: Post Hoc Analysis of the ALLEGRO Trial. Clin J Am Soc Nephrol. 2026 Sep 11. doi: 10.2215/CJN.0000001214. Online ahead of print.
PubMed 42726515van den Born JC, Meziyerh S, Vart P, Bakker SJL, Berger SP, Florquin S, de Fijter JW, Gomes-Neto AW, Idu MM, Pol RA, Roelen DL, van Sandwijk MS, de Vries DK, de Vries APJ, Bemelman FJ, Sanders JSF. Comparison of 2 Immunosuppression Minimization Strategies in Kidney Transplantation: The ALLEGRO Trial. Transplantation. 2024 Feb 1;108(2):556-566. doi: 10.1097/TP.0000000000004776. Epub 2024 Jan 19.
PubMed 37650722
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Free Immunosuppression or Calcineurin Inhibitor Minimization After Basiliximab Induction Therapy in Kidney Transplantation: Comparison With a Standard Quadruple Immunosuppressive Regimen
- ClinicalTrials.gov ID
- NCT01560572
- Acronym / sponsor ID
- Allegro / Allegro
- Conditions
- Renal Insufficiency, Kidney Transplantation
- Keywords
- kidney transplantation, immunosuppression, steroids, tacrolimus OD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- Apr 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Mar 2012 (estimated)
- 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.
A prospective, open, randomized trial, in which the investigators aim to achieve optimal immunosuppression after renal renal transplantation with maximal reduction of side effects, especially of vascular injury, chronic allograft nephropathy, osteoporosis and malignancies. Immunosuppression without steroids and CNI minimization is compared to standard immunosuppression, consisting of tacrolimus OD, mycophenolic acid and corticosteroids.
Detailed description
Before transplantation 300 patients will be randomized 1:1:1 in three groups. Group 1 will be treated with basiliximab induction and a three day course of steroids followed by a steroid free maintenance regimen consisting of standard-dose tacrolimus OD and mycophenolic acid. Group 2 will be treated with Basiliximab induction followed by standard-dose tacrolimus OD, mycophenolic acid and steroids. Group 3 will be treated with basiliximab induction followed by standard-dose tacrolimus OD for six months, whereafter the dose will be reduced plus mycophenolic acid and steroids. The total study period will be 2 years. Primary endpoint will be renal function, proteinuria and microalbuminuria measured 24 months after transplantation. Renal function will be measured by serum Creatinine, Creatinine clearances and CKD-EPI. Secondary endpoints will be the degree of tubular atrophy and interstitial fibrosis and the degree of arteriolar hyalinosis in renal biopsies taken at 12 and 24 months after transplantation. Biopsies will be evaluated according to the Banff Criteria for Renal Allograft Biopsy Interpretation. Quantitative morphometric analysis of interstitial fibrous tissue will be performed using the digital image analysis technique. Other secondary endpoints are patient and graft survival, the incidence of allograft rejection, cardiovascular accidents, pulse wave velocity, blood pressure, the number of antihypertensives, lipid profile, the incidence of malignancies, the incidence of infectious complications, the incidence of post transplant diabetes mellitus and the development of osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard immunosuupression | Active comparator | Drug: tacrolimus OD, mycophenolic acid, prednisolonetriple maintenance immunosuppression with tacrolimus OD (maintenance 6-10 ng/ml), mycophenolic acid 2 dd 540mg and prednisolone 7.5 mg |
| steroidfree | Experimental | Drug: tacrolimus OD, mycophenolic acid, prednisolonemaintenance immunosuppression with tacrolimus OD (target range 6-10 ng/ml), mycophenolic acid (2 dd 540 mg) |
| low dose tacrolimus | Experimental | Drug: tacrolimus OD, mycophenolic acid, prednisolonetriple maintenance immunosuppression with tacrolimus OD (maintenance 6-10 ng/ml), mycophenolic acid 2 dd 540mg and prednisolone 7.5 mg. After 6 months lowering of tacrolimus OD maintenance 3-5 ng/ml |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- recipient of a kidney graft (first of second) from a deceased or living (non-HLA identical) donor
Key exclusion criteria (5 listed)
- patients with multi-organ transplants
- patients who are receiving a third or fourth transplant
- patients who have > 75% (current of historic) panel reactive antibodies
- patients receiving a kidney from a HLA identical living donr
- female patients who are pregnant or unwilling to used adequate contraception during the study
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 OD, mycophenolic acid, prednisoloneAlso: advagraf, mycophenolic acidtacrolimus maintenance 6-10 ng/ml, in the low dose tacrolimus group after 6 months fixed dose reduction of 50% tacrolimus through levels will be 3-5 ng/ml mycophenolic acid 2 dd 720mg, after 2 weeks reduced to 2 dd 540 mg in all groups methylprednisolone 500, 250, 125 mg on day 0, 1, and 2 in all groups prednisolone 1 dd 10 mg, and from week 6 prednisolone 7.5 mg in the standard immunosuppression and low dose tacrolimus group No prednisolone will be given the steroid free group | Drug | low dose tacrolimus, standard immunosuupression, steroidfree |
Primary outcome
renal function parameters
Time frame: 24 months
renal function as measured by serum Creatinine and Creatinine Clearance, CKD-EPI, proteinuria
7 secondary outcomes
tubular atrophy and interstitial fibrosis
Time frame: 24 months
rejection episodes
Time frame: two years
graft and patient survival
Time frame: two years
myocardial infarctions
Time frame: two years
cerebrovascular accidents
Time frame: two years
number of participants with infectious complications
Time frame: two years
number of participants with osteoporosis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 42726515Jonker J, van den Born JC, Kremer D, van Sandwijk MS, Gelinck A, Meziyerh S, Moes DJAR, Smit C, Gomes-Neto AW, Hilhorst M, Vart P, Berger SP, Bakker SJL, Florquin S, de Vries APJ, Bemelman FJ, Touw DJ, Sanders JSF. Plasma versus Whole Blood Tacrolimus Concentration and Outcomes after Kidney Transplantation: Post Hoc Analysis of the ALLEGRO Trial. Clin J Am Soc Nephrol. 2026 Sep 11. doi: 10.2215/CJN.0000001214. Online ahead of print.
- Derived from this study: PubMed 37650722van den Born JC, Meziyerh S, Vart P, Bakker SJL, Berger SP, Florquin S, de Fijter JW, Gomes-Neto AW, Idu MM, Pol RA, Roelen DL, van Sandwijk MS, de Vries DK, de Vries APJ, Bemelman FJ, Sanders JSF. Comparison of 2 Immunosuppression Minimization Strategies in Kidney Transplantation: The ALLEGRO Trial. Transplantation. 2024 Feb 1;108(2):556-566. doi: 10.1097/TP.0000000000004776. Epub 2024 Jan 19.
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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.
Jan-Stephan Sanders, MD, PhD principal investigator
University Medical Center Groningen
3 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 OD, mycophenolic acid, prednisolone in people with Renal Insufficiency and Kidney Transplantation, run by University Medical Center Groningen at 3 sites in Netherlands.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
renal function parameters (time frame: 24 months). 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 NCT01560572, which also lists 2 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 11 Jan 2022.