Back to Search
Start Over
Randomized, Open-Label, Phase IV, Korean Study of Kidney Transplant Patients Converting From Cyclosporine to Prolonged-Release Tacrolimus Plus Standard- or Reduced-Dose Corticosteroids
- Source :
- Transplantation Proceedings. 51:749-760
- Publication Year :
- 2019
- Publisher :
- Elsevier BV, 2019.
-
Abstract
- Background This 24-week, multicenter, randomized, exploratory, comparative, open-label, phase-IV study assessed the safety and efficacy of prolonged-release tacrolimus (PR-T) with reduced-dose versus standard-dose corticosteroids in stable kidney transplant recipients in Korea after converting from cyclosporine-based therapy. Methods At baseline, patients were converted from cyclosporine-based to PR-T-based immunosuppression and randomized (1:1) to receive either corticosteroids maintained at prestudy dose (standard-dose group) or tapered from week 4 to 50% of the prestudy dose by week 12 (reduced-dose group). Patients were seen at baseline and weeks 1, 4, 12, and 24. The primary endpoint was change in estimated glomerular filtration rate (Modification-of-Diet-in-Renal-Disease-4) between baseline and week 24. Secondary endpoints included either acute rejection or patient-reported satisfaction with PR-T. Adverse events (AEs) were recorded. Results Overall, 150 patients were randomized into a reduced-dose group (n = 73) and a standard-dose group (n = 77). At week 24, mean ± standard deviation for corticosteroid dose was 2.5 ± 0.9 mg and 5.0 ± 1.3 mg, respectively. Mean change in estimated glomerular filtration rate from baseline to week 24 was +1.5 ± 9.1 mL/min/1.73 m2 (P = .1567) and +3.4 ± 10.6 mL/min/1.73 m2 (P = .0065), respectively, and not significantly different between groups. There were no acute rejection episodes. Most respondents (>70%) considered PR-T more convenient than cyclosporine. AE incidence was similar between groups. The most common AEs experienced by ≥3% of patients in either treatment group were gastrointestinal events (20.8% and 28.6% of patients receiving reduced- and standard-dose corticosteroids, respectively). Most AEs in both treatment groups were mild or moderate in severity. Conclusion Renal function was maintained following conversion from cyclosporine to PR-T, irrespective of corticosteroid regimen; PR-T enables reduced corticosteroid dosage.
- Subjects :
- Adult
Graft Rejection
Male
medicine.medical_specialty
medicine.drug_class
Urology
Renal function
Tacrolimus
law.invention
Randomized controlled trial
Adrenal Cortex Hormones
law
Republic of Korea
medicine
Clinical endpoint
Humans
Adverse effect
Kidney transplantation
Immunosuppression Therapy
Transplantation
business.industry
Middle Aged
medicine.disease
Kidney Transplantation
Transplant Recipients
Regimen
Patient Satisfaction
Research Design
Delayed-Action Preparations
Cyclosporine
Corticosteroid
Female
Surgery
business
Immunosuppressive Agents
Glomerular Filtration Rate
Subjects
Details
- ISSN :
- 00411345
- Volume :
- 51
- Database :
- OpenAIRE
- Journal :
- Transplantation Proceedings
- Accession number :
- edsair.doi.dedup.....7e0932287e10d1729bfe5b5bdbb28f67