CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Adalimumab +2 moredrug
Likely dose
Adalimumab 24 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00814255
NCT00814255Phase 2Completed
CompareCT.gov

Novel Therapies for Resistant Focal Segmental Glomerulosclerosis

NYU Langone Health·interventional·Posted Dec 24, 2008·Updated Jul 11, 2016

In Brief

A Phase 2 clinical trial evaluating Adalimumab, Lisinopril, losartan, and atorvastatin, and 1 other intervention for Focal Segmental Glomerulosclerosis. Completed, enrolled 32 participants across 18 sites in 2 countries.

Detailed Summary

This project will test whether adalimumab,and/or galactose can safely reduce proteinuria (abnormal amounts of protein in the urine) and protect kidney function better than standard treatment for patients with focal segmental glomerulosclerosis (FSGS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFocal Segmental Glomerulosclerosis
CountriesCanada, United States
CollaboratorsUniversity of Michigan, The Cleveland Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2008
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.5 years ago

Interventions

Adalimumabdrug

Adalimumab 24 mg/m\^2 (maximum dose 40 mg) sc q 14 days

Lisinopril, losartan, and atorvastatindrug

Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day

galactosedrug

galactose 0.2 g/kg/dose (maximum dose 15 g)po BID