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Study | N | Protocol | Status | Outcome |
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ACTHAR gel for drug-resistant nephrotic syndrome in children (ADRENL) | 0 | Acthar 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. | Completed | N/A |
Pilot study of acthar® gel in chronic inflammatory demyelinating neuropathy | 0 | For 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. | Completed | N/A |
Acthar as rescue therapy for transplant glomerulopathy in kidney transplant recipients | 2 | Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. | Completed | N/A |
ACTHAR GEL in patients with membranous (class V) lupus nephritis | 0 | Randomized parallel assignment, 80 IU administered subcutaneously BIW for 6 months. | Completed | N/A |
ACTH treatment of APOL1-associated nephropathy | 0 | Acthar 40 units subcutaneously three times a week or 80 units twice a week. Nonrandomized. | Completed | N/A |
Acthar on proteinuria in IgA nephropathy patients | 0 | Randomized allocation of 80-unit injections 2x weekly. | Completed | N/A |
Use of acthar in patients with FSGS that will be undergoing renal transplantation | 3 | Patients received acthar to measure rate of recurrence of FSGS after transplant. | Completed | N/A |
Safety and efficacy of acthar gel in an outpatient dialysis population | 9 | Randomized with parallel assignment and double masking. Subjects given either 80 or 40 units subcutaneously 2x weekly. | Completed | N/A |
Acthar SLE NYU langone health | 0 | Acthar gel: 40–80 units, once per day | Completed | N/A |
Comparative and efficacy study of acthar gel alone or in combination with tacrolimus in fibrillary glomerulopathy (fact) | 34 | Nonrandomized, 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. | Ongoing | Change 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) | 40 | 4 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. | Ongoing | The level of proteinuria |
Adrenocorticotropic hormone in membranous nephropathy | 25 | Single group assignment. Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly. | Ongoing | Remission of proteinuria |
Dose-finding pilot study of ACTH in patients with idiopathic membranous nephropathy (MN) | 20 | Randomized parallel assignment. Receive ACTH at the dose of 40 or 80 units SQ for up to 12 weeks | Completed | (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) | 20 | Single-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. | Completed | Attainability 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) | 10 | Single group assignment. Patients will administer single dose (80 units) of Acthar subcutaneously every day for 10 days (with a possible 5-day dosing rescue). | Completed | SLEDAI-2K score |
A dose escalation study of long-acting ACTH gel in membranous nephropathy | 10 | Randomized 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. | Completed | Change in proteinuria from baseline to value at 3 months |
Adrenocorticotropic hormone (ACTH) treatment of nephrotic range proteinuria in diabetic nephropathy (NRDN) (ACTH-NRDN) | 14 | Randomized single group assignment. Patients with nephrotic range proteinuria randomized to receive 16 or 32 units of ACTHar gel SQ every day. | Completed | 8 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) | 18 | Nonrandomized singe group assignment, acthar 80 IU·SQ once a week and titrated up to twice a week. | Completed | Acthar has the same antiproteinuric effects in a wide range of glomerulonephritis as seen with synthetic ACTH (synacthen) in Europe |
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