Research Article

ACTH Treatment for Management of Nephrotic Syndrome: A Systematic Review and Reappraisal

Table 2

Summary of clinical trials found on http://www.clinicaltrials.gov.

StudyNProtocolStatusOutcome

ACTHAR gel for drug-resistant nephrotic syndrome in children (ADRENL)0Acthar gel will be dosed by body surface area (BSA) using the dubois method.
The dose of Acthar gel will be 80 units/1.73 m2 per dose administered subcutaneously (SQ) twice a week.
CompletedN/A
Pilot study of acthar® gel in chronic inflammatory demyelinating neuropathy0For the first two weeks, participants will receive 1 mL of study drug subcutaneously every other day. After that, participants will receive 1 mL of study drug twice a week for up to 6 months.CompletedN/A
Acthar as rescue therapy for transplant glomerulopathy in kidney transplant recipients2Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months.CompletedN/A
ACTHAR GEL in patients with membranous (class V) lupus nephritis0Randomized parallel assignment, 80 IU administered subcutaneously BIW for 6 months.CompletedN/A
ACTH treatment of APOL1-associated nephropathy0Acthar 40 units subcutaneously three times a week or 80 units twice a week. Nonrandomized.CompletedN/A
Acthar on proteinuria in IgA nephropathy patients0Randomized allocation of 80-unit injections 2x weekly.CompletedN/A
Use of acthar in patients with FSGS that will be undergoing renal transplantation3Patients received acthar to measure rate of recurrence of FSGS after transplant.CompletedN/A
Safety and efficacy of acthar gel in an outpatient dialysis population9Randomized with parallel assignment and double masking. Subjects given either 80 or 40 units subcutaneously 2x weekly.CompletedN/A
Acthar SLE NYU langone health0Acthar gel: 40–80 units, once per dayCompletedN/A
Comparative and efficacy study of acthar gel alone or in combination with tacrolimus in fibrillary glomerulopathy (fact)34Nonrandomized, single group treatment. ACTHar gel alone-patients will be receive 80 units SQ 2X/week for 52 weeks. ACTH gel 80 units 2X per week plus oral tacrolimus (1.0 mg·BID) titrating to a trough level of 4–6 ng/ml for 52 weeks.OngoingChange in UP/Cr ratio in patients with biopsy-proven fibrillary GN after treatment with ACTHar gel alone OR in combination with oral tacrolimus (time frame: 12 months)
Experience with H. P. acthar gel treatment of patients with nephrotic syndrome/proteinuria due to various etiologies and its effect on podocyte function (acthar)404 treatment periods of 3 months each with 20 units biweekly, 40 units biweekly, and 80 units biweekly, with a tapering period to no drug for the fourth 3-month period. Then one-year follow-up.OngoingThe level of proteinuria
Adrenocorticotropic hormone in membranous nephropathy25Single group assignment. Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly.OngoingRemission of proteinuria
Dose-finding pilot study of ACTH in patients with idiopathic membranous nephropathy (MN)20Randomized parallel assignment. Receive ACTH at the dose of 40 or 80 units SQ for up to 12 weeksCompleted(i) Change in proteinuria, LDL cholesterol, HDL, cholesterol, and triglycerides
(ii) Change in side effects/toxicity
Treatment with synthetic ACTH in high-risk patients with membranous nephropathy (ACTHiMeN)20Single-group assignment intramuscular injections with Tetracosactide hexaacetate (Synacthen Depot) 1 mg/ml. Treatment for 9 months with an increasing dosage from once per 2 weeks to twice a week.CompletedAttainability of ACTH therapy with intramuscular injections twice a week for a period of 9 months, measured as the percentage of injections that has been received in line with the treatment schedule
Open-label trial of Acthar gel in subjects with moderate to severe active systemic lupus erythematosus (ACTH)10Single group assignment. Patients will administer single dose (80 units) of Acthar subcutaneously every day for 10 days (with a possible 5-day dosing rescue).CompletedSLEDAI-2K score
A dose escalation study of long-acting ACTH gel in membranous nephropathy10Randomized parallel assignment: one arm receives 40 units and the second arm 80 units of the ACTH gel subcutaneously, both given in a dose-escalating frequency beginning at once every two weeks escalating to a maximum of twice per week over a total of three months exposed.CompletedChange in proteinuria from baseline to value at 3 months
Adrenocorticotropic hormone (ACTH) treatment of nephrotic range proteinuria in diabetic nephropathy (NRDN) (ACTH-NRDN)14Randomized single group assignment. Patients with nephrotic range proteinuria randomized to receive 16 or 32 units of ACTHar gel SQ every day.Completed8 out of 14 patients achieved a complete (n = 1) or partial (n = 7) remission
Prospective study evaluating the effect of repository corticotropin in the treatment of various nephrotic syndromes (ACTH)18Nonrandomized singe group assignment, acthar 80 IU·SQ once a week and titrated up to twice a week.CompletedActhar has the same antiproteinuric effects in a wide range of glomerulonephritis as seen with synthetic ACTH (synacthen) in Europe