Trial · NCT01601236
Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients
NCT01601236, Phase 2, Completed, Mallinckrodt; results first posted 2017-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients. Trials, record NCT01601236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01601236
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients
- NCT number
- NCT01601236
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Mallinckrodt
- Conditions
- Diabetic Nephropathy
- Interventions
- Repository Corticotropin Injection, Placebo
- First posted
- 2012-05-17
- Last updated
- 2019-11-18
- Results first posted
- 2017-07-24
- Limitations and caveats
Groups 5 \& 6 were closed when 2 of the 1st 4 subjects met predefined tolerability criteria. Enrollment terminated early at 34/40 subjects due to slow recruitment.16 of 34 subjects discontinued prior to collecting primary endpoint data at week 36.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 | Visit 12 (Week 36) | Percent change in eGFR at Visit 12 (Week 36) compared to average baseline eGFR obtained during screening |
| Secondary | Percent Change in eGFR at Visit 17 | Visit 17 (Week 52) | Percent change in eGFR at Visit 17 (Week 52) compared to baseline eGFR obtained during screening |
| Secondary | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 12 (Week 36) and Visit 17 (Week 52) | |
| Secondary | Complete or Partial Remission of Proteinuria | 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) |
| Secondary | Percent Change in eGFR Calculated Using Cystatin C | Visit 12 (Week 36) and Visit 17 (Week 52) | Percent change in eGFR calculated using cystatin C compared to baseline obtained at Visit 2. |
| Secondary | Percent Change From Baseline in eGFR by Visit | 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 |
| Secondary | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Visits 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 | Percent change from baseline in PCR |
| Secondary | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | 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 |
| Secondary | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Visit 6, 9, 12, and 17 | Percent change from baseline of serum total cholesterol, triglycerides, LDL, HDL, Lp(a), albumin, and cortisol |
| Other | Change in Mean HbA1c | Week 36 | Change from baseline mean HbA1c (%) to Week 36 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 | Visit 12 (Week 36) | This trial had an adaptive design that pre-specified the closure of the 32 U (units) (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). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change in eGFR at Visit 17 | Visit 17 (Week 52) | 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). | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 12 (Week 36) and Visit 17 (Week 52) | 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) and Visit 17 (Week 52) | 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in eGFR Calculated Using Cystatin C | Visit 12 (Week 36) and Visit 17 (Week 52) | 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). | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in eGFR by Visit | Visit 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 | 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). | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Visits 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 | 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). | percent change | MEAN |
| SECONDARY | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) and Visit 17 (Week 52) | 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). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Visit 6, 9, 12, and 17 | 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). | percent change | MEAN |
| OTHER_PRE_SPECIFIED | Change in Mean HbA1c | Week 36 | 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). | %HbA1c | MEAN |
Source ClinicalTrials.gov
Results by group285
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 | Placebo | -24.927 | Standard Error 5.4198 | percent change | |
| Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 | Acthar 8 Units | -20.563 | Standard Error 6.8126 | percent change | |
| Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 | Acthar 16 Units | -17.447 | Standard Error 4.3473 | percent change | |
| Percent Change in eGFR at Visit 17 | Placebo | -20.407 | Standard Error 6.0183 | percent change | |
| Percent Change in eGFR at Visit 17 | Acthar 8 Units | -37.456 | Standard Error 7.8387 | percent change | |
| Percent Change in eGFR at Visit 17 | Acthar 16 Units | -22.097 | Standard Error 5.4619 | percent change | |
| Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Placebo | Visit 12 (Week 36) / Yes | 0 | Participants | |
| Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Acthar 8 Units | Visit 12 (Week 36) / Yes | 1 | Participants | |
| Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Acthar 16 Units | Visit 12 (Week 36) / Yes | 1 | Participants | |
| Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Placebo | Visit 12 (Week 36) / No | 10 | Participants |
1 to 10 of 285Source ClinicalTrials.gov
See all 285 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Acthar 8 U (0.1 mL) Daily | 7 | |
| Overall Study | STARTED | Group 2: Placebo (0.1 mL) Daily | 3 | |
| Overall Study | STARTED | Group 3: Acthar 16 U (0.2 mL) Daily | 14 | |
| Overall Study | STARTED | Group 4: Placebo (0.2 mL) Daily | 6 | |
| Overall Study | STARTED | Group 5: Acthar 32 U (0.4 mL) Daily | 3 | |
| Overall Study | STARTED | Group 6: Placebo (0.4 mL) Daily | 1 | |
| Overall Study | COMPLETED | Group 1: Acthar 8 U (0.1 mL) Daily | 2 | |
| Overall Study | COMPLETED | Group 2: Placebo (0.1 mL) Daily | 2 | |
| Overall Study | COMPLETED | Group 3: Acthar 16 U (0.2 mL) Daily | 8 | |
| Overall Study | COMPLETED | Group 4: Placebo (0.2 mL) Daily | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events460
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oedema peripheral | General disorders | Placebo | 2 | 10 | |
| other | Oedema peripheral | General disorders | Acthar 8 Units | 3 | 7 | |
| other | Oedema peripheral | General disorders | Acthar 16 Units | 8 | 17 | |
| other | Oedema peripheral | General disorders | Overall | 13 | 34 | |
| other | Fatigue | General disorders | Placebo | 1 | 10 | |
| other | Fatigue | General disorders | Acthar 8 Units | 0 | 7 | |
| other | Fatigue | General disorders | Acthar 16 Units | 0 | 17 | |
| other | Fatigue | General disorders | Overall | 1 | 34 | |
| other | Injection site bruising | General disorders | Placebo | 1 | 10 | |
| other | Injection site bruising | General disorders | Acthar 8 Units | 0 | 7 |
1 to 10 of 460Source ClinicalTrials.gov
See all 460 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 10 |
| Total, all-cause mortality | Acthar 8 Units | 1 | 7 |
| Total, all-cause mortality | Acthar 16 Units | 0 | 17 |
| Total, all-cause mortality | Overall | 1 | 34 |
| Total, other adverse events | Placebo | 10 | 10 |
| Total, other adverse events | Acthar 8 Units | 6 | 7 |
| Total, other adverse events | Acthar 16 Units | 14 | 17 |
| Total, other adverse events | Overall | 30 | 34 |
| Total, serious adverse events | Placebo | 2 | 10 |
| Total, serious adverse events | Acthar 8 Units | 1 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01601236
GET https://conductscience.org/api/trials/v1/NCT01601236/results?page=2