Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -24.927 | 5.4198 |
| Acthar 8 Units | -20.563 | 6.8126 |
| Acthar 16 Units | -17.447 | 4.3473 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This Phase 2A study is an adaptive design pilot study investigating the efficacy and safety of daily Acthar administration in diabetic patients with nephropathy and proteinuria. Patients with type 1 diabetes mellitus (T1DM) or T2DM who currently take insulin will be enrolled and randomized into 6 study groups and will be treated with either Acthar or Placebo for 36 weeks, followed by a 4 week dose taper, and a 12 week observation period. The study will compare three dose regimens of Acthar (8 U \[0.1 mL\], 16 U \[0.2 mL\], and 32 U \[0.4 mL\]) to equivalent volumes of Placebo to ensure the double-blind nature of the study. Insulin-requiring patients are being enrolled to aid compliance with the daily SC administration of study medication and to allow for ease of blood glucose control by adjustment of current insulin therapy in the event of glycemic excursions. Routine safety measures, including glycemic control, will be monitored throughout the study. The adaptive design component of the study allows for the re-assignment of the high dose group to the mid dose group if unacceptable toxicity is noted as per study protocol in the high dose group. Efficacy will be assessed by monitoring serum creatinine, calculated eGFR, and proteinuria (via urinary protein to creatinine ratio \[PCR\]). Serum cortisol concentration and additional biomarkers in blood and urine will also be monitored.
Experimental
Acthar 8 U (0.1 mL) daily
Repository Corticotropin Injection
Placebo comparator
Placebo (0.1 mL) daily
Placebo
Experimental
Acthar 16 U (0.2 mL) daily
Repository Corticotropin Injection
Placebo comparator
Placebo (0.2 mL) daily
Placebo
Experimental
Acthar 32 U (0.4 mL) daily
Repository Corticotropin Injection
Placebo comparator
Placebo (0.4 mL) daily
Placebo
Outcomes the sponsor listed as primary.
Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12
Time frame · Visit 12 (Week 36)
Percent change in eGFR at Visit 12 (Week 36) compared to average baseline eGFR obtained during screening
Percent Change in eGFR at Visit 17
Time frame · Visit 17 (Week 52)
Percent change in eGFR at Visit 17 (Week 52) compared to baseline eGFR obtained during screening
Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death
Time frame · Visit 12 (Week 36) and Visit 17 (Week 52)
Complete or Partial Remission of Proteinuria
Time frame · Visit 12 (Week 36) and Visit 17 (Week 52)
Proportion of patients with complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of \>50% from baseline, plus PCR≤2.5 g/g but \>0.5 g/g) of proteinuria at Visit 12 (Week 36) and/or at Visit 17 (Week 52)
Percent Change in eGFR Calculated Using Cystatin C
Time frame · Visit 12 (Week 36) and Visit 17 (Week 52)
Percent change in eGFR calculated using cystatin C compared to baseline obtained at Visit 2.
Percent Change From Baseline in eGFR by Visit
Time frame · Visit 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17
Percent change from baseline in eGFR by visit
Percent Change From Baseline in Protein to Creatinine Ratio (PCR)
Time frame · Visits 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17
Percent change from baseline in PCR
Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria
Time frame · Visit 12 (Week 36) and Visit 17 (Week 52)
Proportion of subjects whose best response was complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of \>50% from baseline, plus PCR≤2.5 g/g but \>0.5 g/g) of proteinuria
Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol
Time frame · Visit 6, 9, 12, and 17
Percent change from baseline of serum total cholesterol, triglycerides, LDL, HDL, Lp(a), albumin, and cortisol
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -24.927 | 5.4198 |
| Acthar 8 Units | -20.563 | 6.8126 |
| Acthar 16 Units | -17.447 | 4.3473 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -20.407 | 6.0183 |
| Acthar 8 Units | -37.456 | 7.8387 |
| Acthar 16 Units | -22.097 | 5.4619 |
| Group | Value (Participants) |
|---|---|
| Placebo | 0 |
| Acthar 8 Units | 1 |
| Acthar 16 Units | 1 |
| Group | Value (Participants) |
|---|---|
| Placebo | 0 |
| Acthar 8 Units | 0 |
| Acthar 16 Units | 1 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -14.25 | 17.155 |
| Acthar 8 Units | -11.49 | 10.334 |
| Acthar 16 Units | -10.24 | 22.066 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | -6.19 | 16.494 |
| Acthar 8 Units | 1.82 | 11.347 |
| Acthar 16 Units | 0.86 | 11.659 |
| Group | Value (percent change) | Spread |
|---|---|---|
| Placebo | 0.3837 | 31.26202 |
| Acthar 8 Units | 44.7508 | 78.75623 |
| Acthar 16 Units | 32.5701 | 71.34201 |
| Group | Value (Participants) |
|---|---|
| Placebo | 0 |
| Acthar 8 Units | 0 |
| Acthar 16 Units | 1 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PlaceboGroups 2, 4, 6 | 0 / 10 | 2 / 10 | 10 / 10 |
| Acthar 8 UnitsGroup 1 | 1 / 7 | 1 / 7 | 6 / 7 |
| Acthar 16 UnitsGroups 3, 5; This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3). Thus, Adverse Events were not collected separately for these Arms. | 0 / 17 | 2 / 17 | 14 / 17 |
| OverallGroups 1, 2, 3, 4, 5, 6 | 1 / 34 | 5 / 34 | 30 / 34 |
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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
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