An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression
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...
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| Format: | Article |
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Elsevier
2020-01-01
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| Series: | Kidney International Reports |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2468024919315220 |
| _version_ | 1818120172800573440 |
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| author | Ladan Zand Pietro Canetta Richard Lafayette Nabeel Aslam Novak Jan Sanjeev Sethi Fernando C. Fervenza |
| author_facet | Ladan Zand Pietro Canetta Richard Lafayette Nabeel Aslam Novak Jan Sanjeev Sethi Fernando C. Fervenza |
| author_sort | Ladan Zand |
| collection | DOAJ |
| description | 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. Keywords: ACTH, IgA nephropathy, proteinuria |
| first_indexed | 2024-12-11T05:21:52Z |
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| institution | Directory Open Access Journal |
| issn | 2468-0249 |
| language | English |
| last_indexed | 2024-12-11T05:21:52Z |
| publishDate | 2020-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Kidney International Reports |
| spelling | doaj.art-e72ce0c6c7b54283b2657643edc4f4c22022-12-22T01:19:40ZengElsevierKidney International Reports2468-02492020-01-01515865An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of ProgressionLadan Zand0Pietro Canetta1Richard Lafayette2Nabeel Aslam3Novak Jan4Sanjeev Sethi5Fernando C. Fervenza6Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USADivision of Nephrology and Hypertension, University of Columbia Medical Center, New York, New York, USADivision of Nephrology and Hypertension, Stanford University, Stanford, California, USADivision of Nephrology and Hypertension, Mayo Clinic, Jacksonville, Florida, USADepartment of Microbiology, University of Alabama at Birmingham, Birmingham, Alabama, USADepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USADivision of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA; Correspondence: Fernando C. Fervenza, Division of Nephrology and Hypertension, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55901, USA.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. Keywords: ACTH, IgA nephropathy, proteinuriahttp://www.sciencedirect.com/science/article/pii/S2468024919315220 |
| spellingShingle | Ladan Zand Pietro Canetta Richard Lafayette Nabeel Aslam Novak Jan Sanjeev Sethi Fernando C. Fervenza An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression Kidney International Reports |
| title | An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression |
| title_full | An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression |
| title_fullStr | An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression |
| title_full_unstemmed | An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression |
| title_short | An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression |
| title_sort | open label pilot study of adrenocorticotrophic hormone in the treatment of iga nephropathy at high risk of progression |
| url | http://www.sciencedirect.com/science/article/pii/S2468024919315220 |
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