TP10 Use in Patients With C3 Glomerulopathy (C3G) (NCT02302755) | Clinical Trial Compass
WithdrawnPhase 1
TP10 Use in Patients With C3 Glomerulopathy (C3G)
Stopped: no recruitment
United States0Started 2014-11
Plain-language summary
The purpose of this study is to evaluate the safety of repeated TP10 dosing in pediatric and adult patients with C3G and to evaluate the activity of TP10 in pediatric and adult patients with C3G, as measured by the proportion of patients with normalization of serum C3, serum C3 breakdown products, or alternative pathway (AP) complement activity.
Who can participate
Age range4 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Patient must have C3G as confirmed by renal biopsy within six months of enrollment (confirmation by University of Iowa investigators is required). If the patient is post transplant, the repeat renal transplant biopsy must show C3 dominant glomerulonephritis, and the patient must have a history of known C3G in the native kidney.
ā. C3 serum must be less than 75% of the lower limit of normal.
ā. Signs of alternative pathway dysregulation must be present. C3 breakdown products or C3Nef activity must be detectable in plasma using assays described and validated at the University of Iowa
ā. Serum creatinine level must be abnormal (\>97 percentile for age or \<80 ml/min using the Cockroft Gault equation for adults).
ā. Must have either 24 hour urine protein \>1000 mg/day, or urine protein:creatinine ratio \>1.0.
ā. Screening laboratory values must meet the following criteria:
ā. Must use adequate birth control measures.
ā. Patient must be willing and able to comply with study procedures including vaccination against meningitis, haemophilus and pneumococci at least 2 weeks prior to starting the Induction Period and agree to a renal biopsy at the conclusion of the study.
Exclusion criteria
ā. Dialysis or patients with an estimated glomerular filtration rate (eGFR; using Cockroft Gault equation) of less than 30 ml/min/1.73 m2 for over a four-week period prior to the Screening Period
. Presence or suspicion of active or untreated systemic bacterial infection that in the opinion of the investigator precludes treatment with TP10
ā. Pregnancy or lactation
ā. Rituximab therapy, unless discontinued with B cell levels and immunoglobulin levels normalized by study entry
ā. Patients receiving immunosuppressive therapies (except for low dose steroids \[ā¤10 mg of prednisone or equivalent per day\] given for non-C3G related conditions such as asthma). Patients receiving steroids for C3G must complete a taper prior to study entry. Exceptions will be made for renal transplant patients, who may receive any appropriate therapies as needed to maintain the transplant (i.e., to prevent rejection).
ā. Receipt of any complement inhibitor within 2 months of study entry
ā. Receipt of any other investigational drug or device or experimental procedures beginning four weeks prior to study enrollment
ā. For renal transplant patients only: histology findings of treatable rejection (i.e. that the usual transplant physician would seek to treat). Chronic allograft nephropathy is not exclusionary provided the patient's GFR meets other entry criteria.