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New treatment option for Focal Segmental Glomerulosclerosis
Official title An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Primary Focal Segmental Glomerulosclerosis
ClinicalTrials.gov ID: NCT06664814
What this study is testing
What is ManNAc?
ManNAc is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for focal segmental glomerulosclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: Focal segmental glomerulosclerosis (FSGS) is a disease that causes scarring in parts of the kidneys that filter waste. This can lead to protein loss in the urine, which can worsen kidney function.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 14 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 115
You may be able to join if
- Individuals must meet all the following to be eligible to participate in this study:
- Prior kidney biopsy demonstrating FSGS obtained within 10 years prior to the screening visit.
- Age \>=18 years weighing more than 50 kg.
- If the patient is on immunosuppressive therapy (e.g., prednisone, cyclosporine, tacrolimus or mycophenolate mofetil) he/she should be on these...
- people will be allowed to continue with standard of care (SOC) non-immunosuppressant antiproteinuric agents to include RAAS inhibitors...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Individuals who are unwilling or unable to provide informed consent.
- Individual presenting for initial therapy of uncontrolled nephrotic syndrome which we define as proteinuria as measured by spot urine...
- Individuals who acutely require optimization of volume status with intravenous diuretics to control volume overload, as this may result in fluid...
- Individuals with a psychiatric illness or neurological disease that in the judgement of the investigators would interfere with the ability to adhere...
- Vulnerable individuals, including those with impaired cognitive function or are incarcerated.
See the full eligibility criteria
Who can join
- Individuals must meet all the following to be eligible to participate in this study:
- Prior kidney biopsy demonstrating FSGS obtained within 10 years prior to the screening visit.
- Age \>=18 years weighing more than 50 kg.
- If the patient is on immunosuppressive therapy (e.g., prednisone, cyclosporine, tacrolimus or mycophenolate mofetil) he/she should be on these medications for at least 3 months prior to study evaluation and should be on...
- people will be allowed to continue with standard of care (SOC) non-immunosuppressant antiproteinuric agents to include RAAS inhibitors, mineralocorticoid antagonists (MRA), sodium-glucose co-transporter-2 inhibitors...
- people must have a 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. The rationale for using...
- people with an estimated glomerular filtration rate (eGFR) \>=45 mL/min/1.73/m\^2 using the race-free CKD-EPI 2021 equation based on creatinine and cystatin-C [Inker et al, 2021]. The rationale is that below this eGFR...
- people of reproductive potential must be willing to use at least one effective form of birth control throughout the trial period, unless they have had a permanent birth control procedure/intervention including but not...
- Evidence of a personally signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study and their willingness to comply with all aspects of the study and their...
What rules you out
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Individuals who are unwilling or unable to provide informed consent.
- Individual presenting for initial therapy of uncontrolled nephrotic syndrome which we define as proteinuria as measured by spot urine protein:creatinine ratio \>3g/g or 24-hour urine protein excretion of \>3.5g/day with...
- Individuals who acutely require optimization of volume status with intravenous diuretics to control volume overload, as this may result in fluid shifts between the intravascular space and the remainder of extracellular...
- Individuals with a psychiatric illness or neurological disease that in the judgement of the investigators would interfere with the ability to adhere with the requirements of this protocol. This includes, but is not...
- Vulnerable individuals, including those with impaired cognitive function or are incarcerated.
- Individuals whose renal biopsy shows evidence of an additional pathology along with FSGS.
- Renal biopsy showing interstitial fibrosis and tubular atrophy (IFTA) \>50% per biopsy report.
- Individuals with uncontrolled hypertension with blood pressures consistently \>140/90 mmHg on 3 or more community clinic blood pressure measurements.
- Individuals with clinical evidence of any type of active infection including but not limited to HIV, Hepatitis B and/or Hepatitis C or patients who are positive on screening test for HIV including antibody or viral...
- Individuals with evidence and/or documented history of progressive deterioration of liver functions, including the production of clotting factors, removal of toxic metabolic products, bile excretion for at least 6...
- Individuals with hypertriglyceridemia \>500 mg/dL.
- Individuals with a documented history of malignancy (identified in last 5 years or on active therapy at time of screening).
- Individuals with a documented history of Type I or Type II Diabetes Mellitus
- Individuals with documented history of hematological conditions commonly associated with FSGS such as sickle cell disease and myeloproliferative disorders.
- Individuals with a documented history of cardiac conditions commonly associated with FSGS such as congenital cyanotic heart disease. Individuals with a documented history of connective tissue disorders commonly...
- Individuals taking medications (either currently or within the last 6 months) associated with FSGS such as interferons, lithium, androgenic steroids, sirolimus, heroin, anthracyclines and bisphosphonates.
- Individuals who are pregnant, will be breastfeeding or refuse birth control anytime during the study.
- Individuals who have received treatment with another investigational drug, investigational device, or approved therapy for investigational use less than 60 days prior to planned ManNAc dosing.
- Individuals with hypersensitivity to ManNAc.
- Individuals who have been treated with ManNAc, sialic acid, IVIG, and/or other supplements containing sialic acid (e.g., sialyllactose) less than 60 days prior to planned ManNAc dosing.
- Individuals who received a renal or any other solid organ and/or bone marrow/stem cell transplantation.
- Individuals who in the judgment of the investigator, have a condition that places the subject at increased risk for AEs or has any other illness or clinical condition that might confound the results of the study or pose...
- Patients who need systemic immunosuppressive or glucocorticoid therapy for non-renal indication at any time throughout the trial.
- Any patient receiving rituximab, cyclosphosphamide and/or plasmapheresis within 6 months of screening.
- A documented history of active alcohol and/or substance abuse within the past 2 years.
- Any patient with collapsing FSGS variant on renal biopsy.
- Individuals with clinical history suggesting a post-adaptive FSGS such as those with neonatal history of low birth weight, congenital anomaly of the kidney or urinary tract (CAKUT) based on renal ultrasound findings or...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 14 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 115 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.