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Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT01601236
First received: May 15, 2012
Last updated: July 21, 2017
Last verified: July 2017
Results First Received: May 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Diabetic Nephropathy
Interventions: Drug: Repository Corticotropin Injection
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Initial recruitment target was 40 subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Adaptive design mandated closure of groups 5 & 6 with re-assignment of subjects to groups 3 & 4 if pre-defined tolerability criteria were met in 2 of first 6 patients.

Reporting Groups
  Description
Group 1: Acthar 8 U (0.1 mL) Daily H.P. Acthar Gel (repository corticotropin injection) administered via daily subcutaneous (SC) injection for 36 weeks
Group 2: Placebo (0.1 mL) Daily Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API)administered via daily SC injection for 36 weeks
Group 3: Acthar 16 U (0.2 mL) Daily H.P. Acthar Gel (repository corticotropin injection) administered via daily SC injection for 36 weeks
Group 4: Placebo (0.2 mL) Daily Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the API administered via daily SC injection for 36 weeks
Group 5: Acthar 32 U (0.4 mL) Daily H.P. Acthar Gel (repository corticotropin injection) administered via daily SC injection for 36 weeks
Group 6: Placebo (0.4 mL) Daily Placebo: contains the same inactive ingredients as H.P. Acthar Gel without the API administered via daily SC injection for 36 weeks

Participant Flow:   Overall Study
    Group 1: Acthar 8 U (0.1 mL) Daily   Group 2: Placebo (0.1 mL) Daily   Group 3: Acthar 16 U (0.2 mL) Daily   Group 4: Placebo (0.2 mL) Daily   Group 5: Acthar 32 U (0.4 mL) Daily   Group 6: Placebo (0.4 mL) Daily
STARTED   7   3   14   6   3   1 
COMPLETED   2   2   8   4   0   0 
NOT COMPLETED   5   1   6   2   3   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized subjects

Reporting Groups
  Description
Group 1: Acthar 8 U (0.1 mL) Daily

Repository Corticotropin Injection

Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)].

Group 2: Placebo (0.1 mL) Daily

Placebo

Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes.

Group 3: Acthar 16 U (0.2 mL) Daily

Repository Corticotropin Injection

Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)].

Group 4: Placebo (0.2 mL) Daily

Placebo

Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes.

Group 5: Acthar 32 U (0.4 mL) Daily

Repository Corticotropin Injection

Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)].

Group 6: Placebo (0.4 mL) Daily

Placebo

Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes.

Total Total of all reporting groups

Baseline Measures
   Group 1: Acthar 8 U (0.1 mL) Daily   Group 2: Placebo (0.1 mL) Daily   Group 3: Acthar 16 U (0.2 mL) Daily   Group 4: Placebo (0.2 mL) Daily   Group 5: Acthar 32 U (0.4 mL) Daily   Group 6: Placebo (0.4 mL) Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   3   14   6   3   1   34 
Age 
[Units: Participants]
Count of Participants
             
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6  85.7%      2  66.7%      9  64.3%      5  83.3%      2  66.7%      0   0.0%      24  70.6% 
>=65 years      1  14.3%      1  33.3%      5  35.7%      1  16.7%      1  33.3%      1 100.0%      10  29.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      4  57.1%      0   0.0%      9  64.3%      1  16.7%      1  33.3%      0   0.0%      15  44.1% 
Male      3  42.9%      3 100.0%      5  35.7%      5  83.3%      2  66.7%      1 100.0%      19  55.9% 
Region of Enrollment 
[Units: Participants]
             
United States   7   3   14   6   3   1   34 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12   [ Time Frame: Visit 12 (Week 36) ]

2.  Secondary:   Percent Change in eGFR at Visit 17   [ Time Frame: Visit 17 (Week 52) ]

3.  Secondary:   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) ]

4.  Secondary:   Complete or Partial Remission of Proteinuria   [ Time Frame: Visit 12 (Week 36) and Visit 17 (Week 52) ]

5.  Secondary:   Percent Change in eGFR Calculated Using Cystatin C   [ Time Frame: Visit 12 (Week 36) and Visit 17 (Week 52) ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria   [ Time Frame: Visit 12 (Week 36) and Visit 17 (Week 52) ]

9.  Secondary:   Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol   [ Time Frame: Visit 6, 9, 12, and 17 ]

10.  Other Pre-specified:   Change in Mean HbA1c   [ Time Frame: Week 36 ]

11.  Secondary:   Time to Doubling of Serum Creatinine or ESRD or Death   [ Time Frame: Visit 12 (Week 36) or Visit 17 (Week 52) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Lawrence Hill
Organization: Mallinckrodt
phone: (908) 238-6370
e-mail: lawrence.hill@mallinckrodt.com



Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01601236     History of Changes
Other Study ID Numbers: QSC01-DN-01
Study First Received: May 15, 2012
Results First Received: May 18, 2017
Last Updated: July 21, 2017