An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression

Ladan Zand, Pietro Canetta, Richard Lafayette, Nabeel Aslam, Novak Jan, Sanjeev Sethi, Fernando C. Fervenza

Research output: Contribution to journalArticle

Abstract

Introduction: IgA nephropathy (IgAN) is the most common glomerulonephritis with high risk of progression to end-stage renal disease in patients with proteinuria >1 g/24 hours. There are no known effective treatments in patients with IgAN. Methods: We conducted a prospective open-label pilot study in patients with IgAN using adrenocorticotrophic hormone (ACTH) (Acthar Gel, Mallinckrodt Pharmaceuticals, Bedminster, NJ) at a dosage of 80 units subcutaneously twice weekly for a total of 6 months and followed patients for a total of 12 months. Patients had to have urinary protein >1 g/24 hours despite adequate renin-angiotensin-aldosterone system (RAAS) blockade and estimated glomerular filtration rate (eGFR) >30 ml/min at enrollment. Results: A total of 19 patients were recruited and followed for 1 year. At baseline, the mean age was 34.9 ± 10.5 years with 11 men and 8 women, and 14 Caucasian and 5 Asian individuals. At 12 months, there was a statistically significant decline in 24-hour urinary protein from 2.6 to 1.3 g (P = 0.007) and significant increase in serum albumin (3.79 to 3.93, P = 0.02). There was no significant change in eGFR (65.5 to 61.1 ml/min, P = 0.1). There were 0 complete remissions and 8 partial remissions (42%). There were a total of 6 infections: 2 were viral and 4 required antibiotic therapy (2 sinusitis, 1 pneumonia, 1 otitis media). The most common adverse events included acne, hot flashes, soreness, and anxiety. Conclusion: In summary, patients with IgAN with >1 g/24-hour urinary protein and eGFR >30 ml/min had a significant reduction in 24-hour urinary protein with stable eGFR at 12-month follow-up after being treated with 6 months of ACTH.

Original languageEnglish (US)
Pages (from-to)58-65
Number of pages8
JournalKidney International Reports
Volume5
Issue number1
DOIs
StatePublished - Jan 2020
Externally publishedYes

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Adrenocorticotropic Hormone
Immunoglobulin A
Glomerular Filtration Rate
Therapeutics
Proteins
Hot Flashes
Sinusitis
Acne Vulgaris
Otitis Media
Renin-Angiotensin System
Glomerulonephritis
Proteinuria
Serum Albumin
Chronic Kidney Failure
Pneumonia
Anxiety
Gels
Anti-Bacterial Agents
Infection
Pharmaceutical Preparations

Keywords

  • ACTH
  • IgA nephropathy
  • proteinuria

Cite this

An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression. / Zand, Ladan; Canetta, Pietro; Lafayette, Richard; Aslam, Nabeel; Jan, Novak; Sethi, Sanjeev; Fervenza, Fernando C.

In: Kidney International Reports, Vol. 5, No. 1, 01.2020, p. 58-65.

Research output: Contribution to journalArticle

Zand, Ladan ; Canetta, Pietro ; Lafayette, Richard ; Aslam, Nabeel ; Jan, Novak ; Sethi, Sanjeev ; Fervenza, Fernando C. / An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression. In: Kidney International Reports. 2020 ; Vol. 5, No. 1. pp. 58-65.
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AU - Aslam, Nabeel

AU - Jan, Novak

AU - Sethi, Sanjeev

AU - Fervenza, Fernando C.

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AB - Introduction: IgA nephropathy (IgAN) is the most common glomerulonephritis with high risk of progression to end-stage renal disease in patients with proteinuria >1 g/24 hours. There are no known effective treatments in patients with IgAN. Methods: We conducted a prospective open-label pilot study in patients with IgAN using adrenocorticotrophic hormone (ACTH) (Acthar Gel, Mallinckrodt Pharmaceuticals, Bedminster, NJ) at a dosage of 80 units subcutaneously twice weekly for a total of 6 months and followed patients for a total of 12 months. Patients had to have urinary protein >1 g/24 hours despite adequate renin-angiotensin-aldosterone system (RAAS) blockade and estimated glomerular filtration rate (eGFR) >30 ml/min at enrollment. Results: A total of 19 patients were recruited and followed for 1 year. At baseline, the mean age was 34.9 ± 10.5 years with 11 men and 8 women, and 14 Caucasian and 5 Asian individuals. At 12 months, there was a statistically significant decline in 24-hour urinary protein from 2.6 to 1.3 g (P = 0.007) and significant increase in serum albumin (3.79 to 3.93, P = 0.02). There was no significant change in eGFR (65.5 to 61.1 ml/min, P = 0.1). There were 0 complete remissions and 8 partial remissions (42%). There were a total of 6 infections: 2 were viral and 4 required antibiotic therapy (2 sinusitis, 1 pneumonia, 1 otitis media). The most common adverse events included acne, hot flashes, soreness, and anxiety. Conclusion: In summary, patients with IgAN with >1 g/24-hour urinary protein and eGFR >30 ml/min had a significant reduction in 24-hour urinary protein with stable eGFR at 12-month follow-up after being treated with 6 months of ACTH.

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