Percentage of Participants With Complete or Partial Remission in Proteinuria at 24 Weeks
| Group | Value (Participants) |
|---|---|
| Acthar 40U | 1 |
| Acthar 80U | 5 |
| Combined Placebo | 2 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataShort name CHART
United States, Canada, Chile, Mexico, Turkey (Türkiye)
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to provide nephrologists with additional clinical evidence regarding the efficacy and safety of Acthar in subjects with treatment-resistant idiopathic membranous nephropathy. Approximately sixty (60) subjects will be randomized in this double-blind, parallel-group, placebo-controlled, multicenter study comparing Acthar and Placebo administered 2 times per week for a 24-week treatment period followed by a 24-week observation period. The primary objective of this study is to assess the proportion of treatment-resistant subjects (defined as subjects who either have had no response or have suffered a relapse after achieving a partial response to their most recent standard treatment regimen) who have a complete or partial remission of proteinuria in nephrotic syndrome due to idiopathic membranous nephropathy after 24 weeks of treatment.
Experimental
80 U Acthar
Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) two times per week
Placebo comparator
1.0 mL Placebo
Placebo (1.0 mL) two times per week
Experimental
40 U Acthar
Acthar (Repository Corticotropin Injection) 40 U (1.0 mL) two times per week
Outcomes the sponsor listed as primary.
Percentage of Participants With Complete or Partial Remission in Proteinuria at 24 Weeks
Time frame · At Visit 8 (Week 24)
The participant's response was considered the average of the two PCR values from the 24-hour urine collected at Visit 8 (Week 24). Urine protein creatinine ratio (uPCR) was used to assess remission (partial and complete). Complete remission = uPCR \< 0.3 g/g; partial remission = uPCR \< 50% of baseline uPCR and \> 0.3 g/g but \< 3.0 g/g.
Percentage of Participants With Sustained Remission
Time frame · At Visit 9 (Week 28)
The participant's response was considered the average of the two PCR values from the 24-hour urine collections at Visit 8 (Week 24).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Acthar 40U | 1 |
| Acthar 80U | 5 |
| Combined Placebo | 2 |
| Group | Value (Participants) |
|---|---|
| Acthar 40U | 1 |
| Acthar 80U | 4 |
| Combined Placebo | 2 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Acthar 40U40 U of Acthar administered 5 times a week | 0 / 4 | 1 / 4 | 4 / 4 |
| Acthar 80U80 U of Acthar administered 2 times a week | 0 / 35 | 7 / 35 | 31 / 35 |
| Combined PlaceboPlacebo (volume matched for 40 U or 80 U) administered 5 times (40 U) or 2 times (80 U) per week | 0 / 21 | 3 / 21 | 18 / 21 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Case report · 2011
Bomback et al. 2011Drug design, development and therapycited by 62
PMID 21448451PMC3063118DOI 10.2147/dddt.s17521PUB-21448451
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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