Nephrotic Syndrome Clinical Trial
Official title:
Ofatumumab Versus Rituximab in Children With Steroid and Calcineurin Inhibitor-dependent Idiopathic Nephrotic Syndrome: an Open-label, Randomized, Controlled, Superiority Trial.
Open-label, two-parallel-arm, controlled randomized clinical trial testing the superiority of
Ofatumumab over Rituximab in maintaining steroid- and calcineurin-inhibitor-free disease
remission in SD-INS.
Eligible participants will enter a 1-month run-in period, during which instruction on urine
collection and dipstick readings will be carefully reviewed, compliance assessed, and therapy
with RAS inhibitors withdrawn and, in hypertensive children replaced by other
anti-hypertensive drug.
After run-in period, children will be randomized to either the intervention arm (Ofatumumab)
or the comparator arm (Rituximab).
After infusion of intervention or comparator, steroids will be maintained at initial dose for
30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.
One week after the steroid withdrawal calcineurin inhibitors will be decreased by 50% and
withdrawn within 2 additional weeks.
All patients will be followed for up to 24 months. In case of relapses during the study (see
outcome section for definition) patients will be treated with 60 mg/m2of prednisone p.o. in
order to achieve remission. At remission, patients will be treated with another infusion of
either Oftumumab or Rituximab, according to the initial randomization.
After infusion of intervention or comparator, steroids will be maintained at initial dose for
30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.
One week after the steroid withdrawal calcineurin-inhibitors will be decreased by 50% and
withdrawn within 2 additional weeks. This strategy will be repeated to treat full relapses
during the study.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02238418 -
Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria.
|
Phase 4 | |
| Completed |
NCT01895894 -
Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome
|
Phase 4 | |
| Completed |
NCT01411982 -
Role of PACAP in Nehprotic Syndrome
|
N/A | |
| Recruiting |
NCT00308321 -
Long Term Tapering or Standard Steroids for Nephrotic Syndrome
|
Phase 4 | |
| Active, not recruiting |
NCT03326037 -
Study of The Association of Mutations in The NPHS2 Gene and Nephrotic Syndrome in Children and Adults in Middle East
|
||
| Recruiting |
NCT01240564 -
The Nephrotic Syndrome Study Network (NEPTUNE)
|
N/A | |
| Completed |
NCT01252901 -
Registry for Patients With Wilms' Tumor Suppressor Gene 1 (WT1) Mutation Associated Diseases
|
N/A | |
| Completed |
NCT01197040 -
Evaluation of Low Dose Corticosteroids Efficiency, Associated With Myfortic ® in the Treatment of Nephrotic Syndrome
|
Phase 3 | |
| Terminated |
NCT00883636 -
Cardiomyopathy in Steroid-resistant Nephrotic Syndrome: Impact of Focal Segmental Glomerulosclerosis
|
N/A | |
| Completed |
NCT00035334 -
Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
|
Phase 2/Phase 3 | |
| Terminated |
NCT00004466 -
Pilot Study of Atorvastatin in Children With Chronic Hyperlipidemia Secondary to Nephrotic Syndrome
|
Phase 2 | |
| Terminated |
NCT04558892 -
Anti-Xa Activity of Enoxaparin for Prevention of Venous Thromboembolism in Severe Nephrotic Syndrome.
|
Phase 2/Phase 3 | |
| Completed |
NCT02257697 -
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Refractory Nephrotic Syndrome
|
Phase 3 | |
| Completed |
NCT00362531 -
Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
|
Phase 2/Phase 3 | |
| Completed |
NCT00289328 -
Glucocorticoid-induced Osteopenia in Children
|
N/A | |
| Recruiting |
NCT04759274 -
Diuretic Tuner Clinical Decision Support
|
N/A | |
| Completed |
NCT00001212 -
Drug Therapy in Lupus Nephropathy
|
Phase 2 | |
| Recruiting |
NCT05623033 -
The Predictive Value of Dynamic Changes of CD4+T Lymphocytes in Primary Nephrotic Syndrome With Infection
|
||
| Completed |
NCT03332420 -
The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
|
||
| Not yet recruiting |
NCT05904197 -
Effectiveness of Educational Gamified Cards About Nephrotic Syndrome
|
N/A |