Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Research Trial of Aralast in New Onset Diabetes (RETAIN)

This study has been terminated.
(Due to lack of mechanistic signal and competing industry studies)
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01183468
First received: August 16, 2010
Last updated: January 14, 2015
Last verified: January 2015
Results First Received: January 6, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 1
Interventions: Biological: Aralast NP 45 mg dose
Biological: Aralast NP 90 mg dose
Biological: Aralast NP 180 mg dose

  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
Twelve of the fifteen centers enrolled a total of 17 newly diagnosed (within 100 days of Visit 0 first low dose infusion) Type 1 Diabetes Mellitus participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
Part 1a (Aralast NP)-Subjects 8-15 Yrs Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs

Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.

Aralast NP 90 mg dose: - 90 mg/kg/week

Aralast NP 180 mg dose: - 180 mg/kg/week

Part 1b (Aralast NP)-Subjects 8-17 Yrs

Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.

Aralast NP 90 mg dose: - 90 mg/kg/week

Aralast NP 180 mg dose: - 180 mg/kg/week


Participant Flow:   Overall Study
    Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs     Part 1a (Aralast NP)-Subjects 8-15 Yrs     Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs     Part 1b (Aralast NP)-Subjects 8-17 Yrs  
STARTED     8     9     0     0  
COMPLETED     5     7     0     0  
NOT COMPLETED     3     2     0     0  
Lost to Follow-up                 2                 1                 0                 0  
Physician Decision                 1                 0                 0                 0  
Withdrawal by Subject                 0                 1                 0                 0  



  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.
Enrolled Sample

Reporting Groups
  Description
Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
Part 1a (Aralast NP)-Subjects 8-15 Yrs Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs

Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.

Aralast NP 90 mg dose: - 90 mg/kg/week

Aralast NP 180 mg dose: - 180 mg/kg/week

Part 1b (Aralast NP)-Subjects 8-17 Yrs

Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.

Aralast NP 90 mg dose: - 90 mg/kg/week

Aralast NP 180 mg dose: - 180 mg/kg/week

Total Total of all reporting groups

Baseline Measures
    Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs     Part 1a (Aralast NP)-Subjects 8-15 Yrs     Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs     Part 1b (Aralast NP)-Subjects 8-17 Yrs     Total  
Number of Participants  
[units: participants]
  8     9     0     0     17  
Age  
[units: participants]
         
<=18 years     4     9             13  
Between 18 and 65 years     4     0             4  
>=65 years     0     0             0  
Age  
[units: years]
Mean ± Standard Deviation
  20.6  ± 5.7     10.7  ± 2.2             15.4  ± 6.6  
Gender  
[units: participants]
         
Female     3     3             6  
Male     5     6             11  
Region of Enrollment  
[units: participants]
         
United States     8     9             17  



  Outcome Measures

1.  Primary:   C-peptide 2-hour AUC in Response to a Mixed-meal Tolerance Test at Week 52   [ Time Frame: Week 52 ]


  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
This (Part 1) was the drug dosing portion of the study; however, due to lack of a mechanistic signal and competing industry studies, the study was terminated and the trial portion (Part II, NCT01183455) was withdrawn.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)

Publications automatically indexed to this study:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01183468     History of Changes
Other Study ID Numbers: DAIT ITN041AI Part 1
Study First Received: August 16, 2010
Results First Received: January 6, 2015
Last Updated: January 14, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board