Participation in this study may last up to 2 years (from first visit to final visit) and includes 10 study visits and 8 phone calls.
Subjects will be randomly assigned to one of two treatment groups:
Group A will receive Acthar 80 unit injection 2 times per week or
Group B will receive Acthar 80 unit injection 3 times per week
All participants will be prescribed Lisinopril (10mg per day or higher depending on your blood pressure) as part of regular care for their condition. If they are already on another ACEI, Lisinopril will be prescribed. If subjects are unable to tolerate Lisinopril or other ACEI medications, an angiotensin receptor blocker (ARB) will be prescribed. ARBs are another type of medication that also helps relax blood vessels if subjects cannot tolerate ACEI medications.
Regardless of which treatment group subjects are assigned,everyone will self-inject the study drug using a subcutaneous (SC) injection under the skin using a needle and syringe. Subjects will be trained on the proper technique to be used for each injection before taking study drug home. Enough of the study drug will be given to take home (based on which group the subject is in) to administer until they are seen in 3 months for their next study visit.
Blood samples will be taken for lab tests at each visit and biomarkers (Screening Visit and Visit 9). Women of childbearing potential will also have a pregnancy test done. Approximately 4 teaspoons of blood will be drawn for the Screening Visit and Visit 9.
Subjects must fast at least 8 hours prior to the blood draw.
The following study procedures will be performed:
SCREENING VISIT:
* Informed consent will be obtained;
* Inclusion/exclusion criteria will be assessed, demographics and medical history will be collected (including PCR and urinalysis results as these tests are routinely done as part of regular care);
* Pregnancy test if subject is a female of child bearing potential;
* Physical exam;
* Height/Weight collected;
* Vital signs will be obtained. Blood pressure will be recorded.
* Blood samples collected for study specific tests (aldosterone and cortisol) (approximately 2 teaspoons) and biomarkers (approximately 2 teaspoons). No more than approximately 4 teaspoons will be collected at this study visit;
Subjects who do not meet eligibility criteria during the initial screening attempt will be permitted to rescreen 2 times, for a total of 3 screening attempts. Rescreen subjects must first be registered as screen failed in the CTMS system and subsequently registered as a rescreen subject. Once the subject is registered as rescreened, all screening procedures will need to be repeated.;The exact time interval of each re-screen would be at the discretion of the investigator. Completion of rescreen would be no greater than 6 months from the initial screening date.
VISIT 1 (BASELINE, DAY 0)
* Pregnancy test if subject is a female of child bearing potential
* The first study drug dose in the clinic under the supervision of the study staff. Subject will remain at the clinic for at least 1 hour for monitoring of any allergic reaction.
* Subjects will receive enough study drug (8 for those dosing twice a week and 11 for those dosing three times a week) to take home until their next visit in 3 months. Subjects will also receive a dosing diary to keep track of each dose taken and any side effects they may feel. Subjects will bring dosing diary with them to each study visit on Visits 2-5.
A member of the study staff will also call subjects once a week for the first 4 weeks after starting study drug (Visit 1) to make sure they are taking the study drug as required, completing the dosing diary, if they are taking any other medications and if they are experiencing any side effects. There will be 4 phone calls between Visit 1 and Visit 2.
VISITS 2-5 ONLY (MONTHS 3, 6, 9, 12)
* Dosing diary is collected
* Study medication accountability is recorded.
* Pregnancy test if subject is a female of child bearing potential
* Acthar medication is dispensed (Visits 2-4 only)
* Kidney biopsy performed - Visit 5 only
Kidney biopsy procedure:
Subjects will have to go to nearby hospital within 1 week of completing Visit 5 to have this outpatient procedure done. Subjects will be asked to lie on their stomach face down with a pillow under their rib cage for at least 20 to 30 minutes. Ultrasound may be used to find the proper biopsy site. A local numbing medicine (anesthetic) will be injected under their skin near the biopsy area.
The hospital staff will make a tiny cut in the skin and insert a biopsy needle into the area and to the surface of the kidney. Subjects will be asked to take a deep breath and hold breath as a thin needle is passed through the skin into the kidney. Inside the needle is a sharp edge that will remove small pieces of the kidney. The biopsy needle will then be withdrawn, and pressure will be applied to the biopsy site to stop the minor bleeding that usually occurs after the biopsy. After the procedure, a bandage will be applied to the biopsy site.
The hospital staff will give subject numbing or pain medicines as needed.
VISITS 2-9 (MONTHS 3, 6, 9, 12, 15, 18, 24)
* Inclusion/exclusion criteria will be assessed, demographics and medical history will be collected;
* Physical exam;
* Height/Weight collected;
* Vital signs will be obtained. Blood pressure will be recorded.
* Blood samples collected for study specific tests (aldosterone and cortisol) (approximately 2 teaspoons). Biomarkers (approximately 2 teaspoons) will also be collected at Visit 9. No more than approximately 4 teaspoons will be collected at Visit 9;
After Visit 2, a member of the study staff will continue to call you about every 1 ½ months to make sure subjects are taking the study drug as required, if subjects are taking any other medications and if they are experiencing any side effects. There will be 4 more phone calls that will occur between Visit 2-3, Visit 3-4, Visit 4-5 and Visit 5-6. Subjects will receive a total of 8 phone calls during this study.
The total amount of blood collected over the course of this study is no more than approximately 38 teaspoons.
Treatment with the study drugs will continue for the first 12 months of participation in this study. If subjects do not respond after 3 months of treatment or only partially respond to the treatment, dosage may be increased (up to 120 unit injections twice a week for 3 months). If subjects still do not respond at the increased dose, the study drug will be discontinued after another 3 months of treatment.
If subjects respond to the treatment during the 12 months of treatment but then their response goes away during the follow up period, they will be placed back on study drug for an additional 6 months.
If, for any reason, the study drug is stopped before the last treatment visit, subjects will be asked to come into the clinic to complete study procedures. Subjects will be asked to have all end-of-study testing done for safety.
Acthar cannot be abruptly stopped and must be gradually lessened. Except if subjects are experiencing an allergic reaction, the drug will be administered at half the dose for 1 week, then ¼ dose for another week, then stopped.
If subjects are on insulin or other oral antidiabetic medications, Acthar may decrease glucose (sugar) tolerance. This may result in an increase blood sugar. Subjects will be asked to let the study doctor know if they are on these medications to discuss glucose monitoring and a plan on how to keep taking these medications while on Acthar and what to do if they experience an increase in blood sugar.
