ACTHAR Gel for Drug REsistant Nephrotic Syndrome in Children (ADRENL)
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|ClinicalTrials.gov Identifier: NCT03408405|
Recruitment Status : Not yet recruiting
First Posted : January 24, 2018
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Steroid-Resistant Nephrotic Syndrome||Drug: Acthar Gel 80 UNT/ML Injectable Solution||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|Official Title:||ADRENL - ACTHAR Gel for Drug REsistant Nephrotic Syndrome in Children, Pilot Study|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: Acthar Gel treatment group
Participants will be treated with 'Acthar Gel 80 UNT/ML Injectable Solution'. Initial dose for week 1 will be 50% of 80 units, injected twice per week. Week 2 is 75% of 80 units, week 3 and throughout treatment period (6 months in total) will be 80 units/ml twice per week.
Drug: Acthar Gel 80 UNT/ML Injectable Solution
Participant will self inject 'Acthar Gel 80 UNT/ML Injectable Solution' 2 x per week for six months.
Other Name: H.P. Acthar gel
- Remission of proteinuria [ Time Frame: 18 months ]
Partial remission: Greater than or equal to 50% reduction in proteinuria when compared to baseline.
Complete remission: Greater than or equal to 90% reduction in proteinuria when compared to baseline or Urine Protein Creatinine ratio less than 0.5.
- Blood pressure [ Time Frame: 18 months ]Blood pressure during study visit as measured in mm/Hg
- Serum Creatinine [ Time Frame: 18 months ]Serum value in mg/dL
- BMI [ Time Frame: 18 months ]Weight (kgs) and height (cms) will be combined to report BMI in kg/m^2
- Serum Glucose [ Time Frame: 18 months ]Serum value in mg/dL
- Serum Lipids [ Time Frame: 18 months ]Serum Value in mg/dL
- Quality of life measures obtained via survey [ Time Frame: 18 months ]PedsQL 3.0 will be used as the standardized survey tool
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408405
|Contact: Mohammed K Faizan, MDemail@example.com|
|Contact: Evelyn Tolbert, MS||401-444-4566||ADRENLstudyinfo@Lifespan.org|
|Principal Investigator:||Mohammed K Faizan, MD||Rhode Island Hospital|