The most important problem after kidney transplantation is the occurrence of chronic interstitial fibrosis (IF) and tubular atrophy (TA), which leads to graft loss. Tacrolimus induced nephrotoxicity importantly contributes to the development of IF/…
ID
Bron
Verkorte titel
Aandoening
Kidney transplant recipients
Tacrolimus
Everolimus
Niertransplantatie patiënten
Ondersteuning
Novartis
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
For this conversion study renal function is the primary endpoint. Mean MDRD clearances will be compared between tacrolimus and everolimus treated patients at month 12. Also changes in MDRD clearances within individual patients in the tacrolimus and everolimus treated patients between month 3 and 12 will be compared.
Achtergrond van het onderzoek
Rationale:
The most important problem after kidney transplantation is the occurrence of chronic interstitial fibrosis (IF) and tubular atrophy (TA), which leads to graft loss. Tacrolimus induced nephrotoxicity importantly contributes to the development of IF/TA. By converting tacrolimus maintenance therapy to everolimus the nephrotoxic side effects of this drug will be eliminated tacrolimus and renal function may be preserved.
Objective:
To investigate if conversion of tacrolimus-based immunosuppression to everolimus-based immunosuppression results in preservation of renal function as compared to continued tacrolimus-based immunosuppression. In addition to renal function also changes in renal histology following conversion of tacrolimus-based immunosuppression to everolimus-based immunosuppression will be studied.
Study design:
A randomized, controlled parallel study: At three months after transplantation patients will be randomised for continuation of tacrolimus or conversion to everolimus maintenance therapy.
Intervention:
One group will continue tacrolimus three months after transplantation and the other group will be converted to everolimus three months after transplantation.
Main study parameters/endpoints:
Renal function is the primary endpoint. Mean
glomerular filtration rate (GFR; calculated by use of the MDRD formula) will be compared between tacrolimus and everolimus treated patients at month 12. In addition, differences in MDRD GFR within individual patients in the tacrolimus and everolimus treated patients between month 3 and 12 will be compared.
Doel van het onderzoek
The most important problem after kidney transplantation is the occurrence of chronic interstitial fibrosis (IF) and tubular atrophy (TA), which leads to graft loss. Tacrolimus
induced nephrotoxicity importantly contributes to the development of IF/TA. By converting tacrolimus maintenance therapy to everolimus the nephrotoxic side effects of this drug will be eliminated tacrolimus and renal function may be preserved.
Onderzoeksopzet
Month 3 after kidney transplantation.
Onderzoeksproduct en/of interventie
Conversion of tacrolimus-based immunosuppression to everolimus-based immunosuppression three months after kidney transplantation. At three months after transplantation patients will be randomized for continuation of tacrolimus or conversion to everolimus maintenance therapy.
Publiek
W. Weimar
Erasmus Medical Center, Department of Internal Medicine
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7034607
Wetenschappelijk
W. Weimar
Erasmus Medical Center, Department of Internal Medicine
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7034607
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Treatment with immunosuppressive therapy consisting of tacrolimus, corticosteroids and mycophenolate mofetil at 3 months after transplantation;
2. Patients who have given written informed consent to participate in the study.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Acute rejection episodes less than 4 weeks prior to randomization;
2. Proteinuria ≥ 1.0 g/day;
3. GFR ≤ 30 mL/min;
4. Recipient of multiple organ transplants;
5. Recipient of ABO incompatible allograft or a positive cross-match;
6. Patient who is human immunodeficiency virus (HIV) positive;
7. Patient who received an allograft from a Hepatitis B surface Antigen (HBsAg) or a Hepatitis C Virus (HCV) positive donor;
8. Patient with severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment that would prevent patient from potential exposure to everolimus, or with
hypersensitivity to drugs similar to everolimus (e.g. macrolides);
9. Patient with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled;
10. Patient with white blood cell (WBC) count ¡Ü 2,000 /mm3 or with platelet count ≤ 50,000 /mm3;
11. Patients with ongoing wound healing problems, clinically significant infection requiring continued therapy or other severe surgical complication in the opinion of the
investigator;
12. Presence of intractable immunosuppressant complications or side effects;
13. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2436 |
| NTR-old | NTR2545 |
| Ander register | EudraCT : 2010-019398-14 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |