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ManNAc for FSGS
Phase 2
Waitlist Available
Led By William A Gahl, M.D.
Research Sponsored by National Human Genome Research Institute (NHGRI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >=18 years weighing more than 50 kg
Subjects must have spot random urine PCR of >= 2g/g on each of 3 measurements collected on at least 2 separate days during screening period plus a 24-hr urine protein collection of >= 2g/day
Must not have
Individuals presenting for initial therapy of uncontrolled nephrotic syndrome
Individuals acutely requiring optimization of volume status with intravenous diuretics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a new drug called ManNAc in adults with FSGS, a kidney disease that can lead to kidney failure. Participants will take the drug twice a day for 14 weeks
Who is the study for?
This trial is for adults aged 18 and older diagnosed with Focal Segmental Glomerulosclerosis (FSGS), a kidney disease that causes scarring and can lead to protein loss in urine. Participants will need to attend several clinic visits, some requiring overnight stays.
What is being tested?
The study is testing ManNAc, a white powder dissolved in water taken orally twice daily, as a potential treatment for FSGS. The trial includes regular clinic visits for physical exams, blood and urine tests, health questionnaires, and possible dietary consultations.
What are the potential side effects?
Participants are asked to record any adverse effects of ManNAc in their diaries at home. Specific side effects aren't listed here but monitoring during the study includes follow-up calls every two weeks after each visit.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and weigh more than 50 kg.
Select...
My urine tests show high protein levels on multiple tests.
Select...
My kidney function is normal or only mildly reduced.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am seeking treatment for the first time for uncontrolled nephrotic syndrome.
Select...
I need IV diuretics to manage my fluid levels urgently.
Select...
I currently have an active infection.
Select...
My liver function is getting worse over time.
Select...
My kidney biopsy shows FSGS and other conditions.
Select...
My high blood pressure is not under control.
Select...
I have had cancer in the past 5 years.
Select...
I am on medication for FSGS.
Select...
I am not pregnant, breastfeeding, and I agree to use birth control.
Select...
I need immunosuppressive drugs for a condition other than kidney disease.
Select...
My kidney biopsy shows I have the collapsing form of FSGS.
Select...
I have a history of FSGS after adapting to changes in my body.
Select...
I have Type I or Type II Diabetes.
Select...
I have received rituximab, cyclophosphamide, or plasmapheresis in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2018 Phase 2 trial • 12 Patients • NCT0234646133%
Abdominal distension
33%
Alanine aminotransferase increased
33%
Blood creatine phosphokinase increased
33%
Hypertriglyceridaemia
33%
Obesity
33%
Flatulence
17%
Aspartate aminotransferase increased
17%
Skin induration
17%
Abdominal pain
17%
Constipation
17%
Hyperglycaemia
17%
Oedema peripheral
17%
Pain
17%
Rash maculo-papular
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
ManNAc 3 g - 7 Days
ManNAc 6 g - 7 Days
ManNAc 6 g - Day 8 to 30 Months
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: open label, single armExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ManNAc
2015
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
National Human Genome Research Institute (NHGRI)Lead Sponsor
270 Previous Clinical Trials
294,039 Total Patients Enrolled
William A Gahl, M.D.Principal InvestigatorNational Human Genome Research Institute (NHGRI)
10 Previous Clinical Trials
25,070 Total Patients Enrolled