Abstract: TH-PO1206
Randomized Controlled Trial of Tacrolimus vs. Prednisolone Monotherapy for Adults with De Novo Minimal Change Disease
Session Information
- Late-Breaking Clinical Trials Posters
November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- No subcategory defined
Authors
- Griffith, Megan, Imperial College NHS Trust, London, United Kingdom
- Medjeral-Thomas, Nicholas R., Imperial College London, London, United Kingdom
Group or Team Name
- MInTac Study Investigators
Background
Standard treatment of de novo nephrotic syndrome secondary to Minimal Change Disease with high dose corticosteroids is associated with the risk of adverse side effects. However there is a paucity of Clinical Trials to guide the use of steroid free alternative regimens in this rare disease in adults. This multicentre prospective, open-label, randomised controlled trial (EudraCT 2009-014292-52, ClinicalTrials.gov NCT00982072) involving 6 nephrology units across the UK investigated whether tacrolimus monotherapy without corticosteroids would be effective for the treatment of de novo minimal change disease. We hypothesised nephrotic syndrome remission rates would be non-inferior for tacrolimus monotherapy compared to corticosteroids
Methods
Adult patients with first presentation of minimal change disease and nephrotic syndrome were randomised to oral tacrolimus at 0.05mg/kg twice daily, or prednisolone at 1mg/kg daily up to 60mg daily. 50 patients completed the trial
Results
There were no significant differences between the tacrolimus and prednisolone treated cohorts in the proportion of patients in complete remission at 8 weeks (primary outcome; 21 of 25 (84%) for prednisolone and 17 of 25 (68%) for tacrolimus (p=0.32)), at 16 weeks (23 of 25 (92%) for prednisolone and 19 of 25 (76%) for tacrolimus (p=0.25)), or at 26 weeks (23 of 25 (92%) for prednisolone and 22 of 25 (88%) for tacrolimus (p>0.99)). Likewise there was no difference in total remission rates (complete or partial) at 4 weeks (20 of 25 patients (80%) in the prednisolone and 19 of 25 patients (76%) in the tacrolimus cohort (p>0.99), or at the subsequent time points. There was no significant difference in relapse rates (17 of 23 (74%) for prednisolone and 16 of 22 (70%) for tacrolimus (p>0.99)), in the time from complete remission to relapse, or in changes from baseline serum creatinine.
Conclusion
Tacrolimus monotherapy treatment for adults with newly presenting minimal change disease was non-inferior to oral prednisolone in achieving remission from nephrotic syndrome. This is the 1st multicentre randomised controlled trial demonstrating an effective alternative for patients wishing to avoid steroid therapy. This heralds a new era in the management of adults with minimal change disease.