NCT03501459

Brief Summary

The purpose of this study is to investigate if lymphocyte markers predict response to rituximab among patients with idiopathic nephrotic syndrome

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

12.5 years

First QC Date

April 10, 2018

Last Update Submit

August 24, 2019

Conditions

Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Response

    Resolution of proteinuria (urine protein:creatinine \<0.02 g/mmol or urine protein excretion \<0.3 g/1.73m2/day) and ability to wean off prednisolone and calcineurin inhibitor at three months after the last dose of rituximab.

    3 months

Study Arms (1)

Rituximab

EXPERIMENTAL
Drug: Rituximab

Interventions

RituximabDRUG
Rituximab

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 1-18 years old at the time of diagnosis of nephrotic syndrome
  • Steroid-dependent (SDNS) or steroid-resistant nephrotic syndrome (SDNS)

You may not qualify if:

  • eGFR \<60 ml/min per 1.73m2
  • infantile onset of nephrotic syndrome
  • nephrotic syndrome secondary to chronic infections such as hepatitis B, hepatitis C or human immunodeficiency virus, systemic lupus erythematosus, Henoch-Schönlein purpura, IgA nephropathy, membranoproliferative glomerulonephritis or membranous nephropathy
  • current or previous therapy for tuberculosis
  • presence of mutations in WT1, NPHS1, NPHS2 and TRPC6.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Rituximab

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Hui-Kim Yap

CONTACT

hui_kim_yap@nuhs.edu.sg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Yap Hui Kim

Study Record Dates

First Submitted

April 10, 2018

First Posted

April 18, 2018

Study Start

June 1, 2008

Primary Completion

December 1, 2020

Study Completion

December 1, 2025

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

SG(1)