Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT02057523|
Recruitment Status : Unknown
Verified December 2014 by Sanjeev Akkina, University of Illinois at Chicago.
Recruitment status was: Recruiting
First Posted : February 7, 2014
Last Update Posted : December 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Proteinuria Transplant Glomerulopathy||Drug: Acthar||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||September 2016|
Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.
Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.
- 50% Reduction in Proteinuria or Proteinuria < 150mg/day [ Time Frame: 6 months ]
- 25% Improvement in the MDRD eGFR [ Time Frame: 6 months ]
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): NCT02057523
|Contact: Sanjeev Akkina, MDfirstname.lastname@example.org|
|Contact: Maya Campara, PharmD||312-996-0897 ext email@example.com|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Sanjeev Akkina, MD 312-996-8075 firstname.lastname@example.org|
|Contact: Maya Campara, PharmD 312-996-0897 email@example.com|
|Principal Investigator: Sanjeev Akkina, MD|
|Principal Investigator:||Sanjeev Akkina, MD||University of Illinois at Chicago|