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| Name | Class |
|---|---|
| Leiden University Medical Center | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| steroidfree | Experimental | maintenance immunosuppression with tacrolimus OD (target range 6-10 ng/ml), mycophenolic acid (2 dd 540 mg) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus OD, mycophenolic acid, prednisolone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| renal function parameters | renal function as measured by serum Creatinine and Creatinine Clearance, CKD-EPI, proteinuria | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| tubular atrophy and interstitial fibrosis | tubular atrophy and interstitial fibrosis in renal biopsies | 24 months |
| rejection episodes | number of treated biopsy proven acute rejection episodes (as scored by pathologist via Banff classification) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan-Stephan Sanders, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academisch Medisch Centrum | Amsterdam | Netherlands | ||||
| University Medical Center Groningen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37650722 | Derived | van 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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|
|
| two years |
| graft and patient survival | graft and patient survival | two years |
| myocardial infarctions | number of myocardial infarctions | two years |
| cerebrovascular accidents | number of cerebrovascular accidents | two years |
| number of participants with infectious complications | bacterial and viral infections as measured by culture (bacterial infections) or PCR (viral infections) | two years |
| number of participants with osteoporosis | as established by dexa bone densitometry | 2 years |
| Groningen |
| Netherlands |
| Leiden University Medical Center | Leiden | Netherlands |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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