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Original ArticlesClinical Nephrology
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Treatment of Idiopathic FSGS with Adrenocorticotropic Hormone Gel

Jonathan Hogan, Andrew S. Bomback, Kshama Mehta, Pietro A. Canetta, Maya K. Rao, Gerald B. Appel, Jai Radhakrishnan and Richard A. Lafayette
CJASN December 2013, 8 (12) 2072-2081; DOI: https://doi.org/10.2215/CJN.02840313
Jonathan Hogan
*Division of Nephrology, Department of Medicine, Columbia University Medical Center, New York, New York, and
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Andrew S. Bomback
*Division of Nephrology, Department of Medicine, Columbia University Medical Center, New York, New York, and
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Kshama Mehta
†Department of Medicine, Division of Nephrology, Stanford University, Stanford, California
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Pietro A. Canetta
*Division of Nephrology, Department of Medicine, Columbia University Medical Center, New York, New York, and
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Maya K. Rao
*Division of Nephrology, Department of Medicine, Columbia University Medical Center, New York, New York, and
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Gerald B. Appel
*Division of Nephrology, Department of Medicine, Columbia University Medical Center, New York, New York, and
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Jai Radhakrishnan
*Division of Nephrology, Department of Medicine, Columbia University Medical Center, New York, New York, and
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Richard A. Lafayette
†Department of Medicine, Division of Nephrology, Stanford University, Stanford, California
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    Figure 1.

    Proteinuria trend versus time for seven patients who achieved remission with adrenocorticotropic hormone (ACTH). Time zero demarcates the end of the ACTH treatment course for each patient. Patients 15 and 23 experienced relapse after ACTH therapy, with patient 15 not meeting remission criteria because of worsened renal function, and patient 23 attaining remission in proteinuria with a repeat course of Stanford Protocol ACTH but not meeting criteria for remission based on serum creatinine. Additional immunosuppressive therapy used during follow-up period: patient 3, mycophenolate mofetil and tacrolimus; patient 12, mycophenolate mofetil; patient 23, cyclosporine and ACTH.

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    Table 1.

    Baseline data for patients with FSGS treated with adrenocorticotropic hormone

    PatientAge/(yr)/SexRace/EthnicityFSGS MorphologyPrevious ImmunosuppressionSteroid Response CategoryTime from Diagnosis to Treatment (mo)Serum Creatinine (mg/dl)eGFR (ml/min per 1.73 m2)Proteinuria (mg/g)
    Columbia patients
     142/MaleWNHNOSSteroids, MMF, tacrolimusaSR2b2.7287000
     238/FemaleBNHNOSSteroids, MMF, cyclosporineSR562.3315046
     321/FemaleWNHTipSteroids, tacrolimus, cyclosporineSD121.1675200
     440/MaleWNHTipSteroids, tacrolimus, cyclosporine, MMFSR961.2712100
     518/MaleBNHTipSteroids, tacrolimus, MMFSR132.64211,200
     646/MaleWNHNOSSteroids, cyclophosphamide, MMF, tacrolimusSD303.22316,800
     764/FemaleWHCellularSteroids, MMF, tacrolimus,SD611.63510,300
     860/FemaleWNHCellularSteroids, tacrolimus, MMF, cyclosporineSR232.3232300
     966/MaleWNHTipSteroids, cyclosporine, MMFSR1321.0661600
     1036/MaleWNHNOSSteroids, cyclosporineSR960.81162200
     1130/FemaleWNHTipSteroids, MMF, cyclosporine, tacrolimusSR133.4178800
     1247/FemaleBHTipSteroids, tacrolimusaSR43.61715,200
    Stanford patients
     1366/MaleWHNOSSteroidsSR142.2302020
     1465/MaleWNHCellularNoneNA82.7243170
     1564/MaleWNHNOSSteroidsSD221.04767240
     1627/MaleWHNOSSteroids, cyclosporineSR282.99352200
     1758/MaleWNHTipNoneNA42.2323550
     1829/MaleBNHCollapsingSteroids, MMFSR63.32823,800
     1928/FemaleWHTipCyclosporineNA190.61244860
     2040/MaleWHNOSSteroidsSD291.1842320
     2139/FemaleWHTipSteroids, MMFSR241.7371710
     2269/FemaleWNHTipSteroids, tacrolimusSR940.6934330
     2356/FemaleWNHCellularSteroidsSR21.1566560
     2439/MaleWHTipSteroids, cyclosporineSD291.0942000
    • eGFR, estimated GFR; WNH, white non-Hispanic; NOS, not otherwise specified; MMF, mycophenolate mofetil; SR, steroid resistant; BNH, black Non-Hispanic; SD, steroid dependent; WH, white Hispanic; BH, black Hispanic; NA, not applicable.

    • ↵a Patients 1 and 12 also underwent plasma exchange therapy.

    • ↵b Patient 1 had undergone four prior renal transplants for recurrent FSGS and was diagnosed with another recurrence 2 months before starting ACTH.

    • View popup
    Table 2.

    Baseline characteristics for all patients

    CharacteristicValue
    Mean age ± SD (yr)45.3±15.8
    Sex (n)
     Male14
     Female10
    Race/ethnicity (n)
     White non-Hispanic 13
     White Hispanic7
     Black non-Hispanic3
     Black Hispanic1
    FSGS morphology (n)
     Tip11
     NOS8
     Cellular4
     Collapsing1
    Previous immunomodulatory drugs used (n)
     02
     15
     27
     35
     45
    Serum creatinine (mg/dl)2.0 (1.1–2.7)
    eGFR (ml/min per 1.73 m2)36 (28–78)
    Proteinuria (mg/g)4595 (2200–8020)
    Time from diagnosis to treatment (mo)23 (10–43)
    Steroid response category (n)
     SDNS6
     SRNS15
     NA3
    • Values with ranges in parentheses are medians and interquartile ranges. NOS, not otherwise specified; eGFR, estimate GFR; SDNS, steroid-dependent nephrotic syndrome; SRNS, steroid-resistant nephrotic syndrome; NA, not applicable.

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    Table 3.

    Treatment regimens, data pre- and post-adrenocorticotropic hormone, and outcome category for patients with FSGS treated with adrenocorticotropic hormone

    PatientTreatment RegimenIMD during ACTH TherapyDuration of ACTH Therapy (wk)Change in Laboratory Values before/after ACTH TreatmentOutcome
    VariableInitialFinal
    Columbia patients
     1ColumbiaTacrolimus, mycophenolic acida,b15Scr (mg/dl)2.73.7Failed
    Proteinuria (mg/g)70002841
    Albumin (g/dl)3.73.7
     2ColumbiaNone24Scr (mg/dl)2.31.3Partial
    Proteinuria (mg/g)5046963
    Albumin (g/dl)2.13.4
     3IndividualTacrolimus36Scr (mg/dl)1.10.7Partial
    Proteinuria (mg/g)52001500
    Albumin (g/dl)1.93.4
     4ColumbiaNone24Scr (mg/dl)1.21.4Complete
    Proteinuria (mg/g)2100272
    Albumin (g/dl)3.74.0
     5IndividualCyclosporine34Scr (mg/dl)2.61.1Failed
    Proteinuria (mg/g)11,2007789
    Albumin (g/dl)1.32.3
     6ColumbiaNone12Scr (mg/dl)3.22.9Failed
    Proteinuria (mg/g)16,80025,000
    Albumin (g/dl)1.61.4
     7IndividualNone56Scr (mg/dl)1.61.2Failed
    Proteinuria (mg/g)10,3005380
    Albumin (g/dl)2.03.3
     8ColumbiaNone28Scr (mg/dl)2.31.7Failed
    Proteinuria (mg/g)23005620
    Albumin (g/dl)2.93.6
     9ColumbiaNone23Scr (mg/dl)1.01.0Failed
    Proteinuria (mg/g)16001900
    Albumin (g/dl)3.63.8
     10ColumbiaCyclosporine19Scr (mg/dl)0.80.9Failed
    Proteinuria (mg/g)22003847
    Albumin (g/dl)2.92.4
     11IndividualMMF36Scr (mg/dl)3.41.5Failed
    Proteinuria (mg/g)88009500
    Albumin (g/dl)2.31.6
     12IndividualNoneb36Scr (mg/dl)3.61.3Partial
    Proteinuria (mg/g)15,200891
    Albumin (g/dl)2.13.4
    Stanford patients
     13StanfordNone16Scr (mg/dl)2.22.2Failed
    Proteinuria (mg/g)20201620
    Albumin (g/dl)3.83.9
     14StanfordNone16Scr (mg/dl)2.72.9Failed
    Proteinuria (mg/g)31702240
    Albumin (g/dl)2.9NA
     15StanfordNone16Scr (mg/dl)1.01.1Partial
    Proteinuria (mg/g)72401940
    Albumin (g/dl)NA3.3
     16StanfordNone16Scr (mg/dl)3.02.7Failed
    Proteinuria (mg/g)22002240
    Albumin (g/dl)4.8NA
     17StanfordNone16Scr (mg/dl)2.22.1Failed
    Proteinuria (mg/g)35504580
    Albumin (g/dl)4.33.6
     18StanfordNone16Scr (mg/dl)3.33.9Failed
    Proteinuria (mg/g)23,80018,600
    Albumin (g/dl)1.72.8
     19StanfordNone16Scr (mg/dl)0.6NALost to follow-up
    Proteinuria (mg/g)4860NA
    Albumin (g/dl)2.4NA
     20StanfordNone16Scr (mg/dl)1.11.1Failed
    Proteinuria (mg/g)23201570
    Albumin (g/dl)3.43.8
     21StanfordNone16Scr (mg/dl)1.72.0Failed
    Proteinuria (mg/g)17103230
    Albumin (g/dl)3.23.9
     22StanfordNone16Scr (mg/dl)0.60.7Complete
    Proteinuria (mg/g)4330270
    Albumin (g/dl)1.73.6
     23StanfordNone16Scr (mg/dl)1.11.2Partial
    Proteinuria (mg/g)65602120
    Albumin (g/dl)2.22.1
     24StanfordNone16Scr (mg/dl)1.01.7Failed
    Proteinuria (mg/g)20006100
    Albumin (g/dl)3.3NA
    • Patient 19 was lost to follow-up. Columbia protocol: 80 units subcutaneously (SC) twice weekly for 24 weeks. Stanford protocol: 40 units subcutaneously weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy. Individual treatment regimens: Patient 3: 80 units twice weekly for 18 weeks, then 80 units weekly for 18 weeks; patient 5: 80 units twice weekly for 16 weeks, then three times weekly for 18 weeks; patient 7: 80 units twice weekly for 24 weeks, then 50 units twice weekly for 10 weeks, then 50–80 units weekly for 22 weeks; patient 11: 80 units twice weekly for 20 weeks, then 40 units twice weekly for 16 weeks; patient 12: 80 units twice weekly for 13 weeks, then 80 units weekly for 21 weeks. IMD, immunosuppressive drugs; ACTH, adrenocorticotropic hormone; Scr, serum creatinine, MMF, mycophenolate mofetil; NA, not applicable.

    • ↵a Patient 1 had undergone four prior renal transplants for recurrent FSGS and was diagnosed with another recurrence 2 months before starting ACTH.

    • ↵b Patient 1 underwent plasma exchange therapy; patient 12 completed plasma exchange therapy during week 1 of ACTH therapy.

    • View popup
    Table 4.

    Baseline characteristics and treatment regimen, organized by response category during adrenocorticotropic hormone therapy

    VariableSteroid Response Category (n)Age (yr)Sex (n)Race/Ethnicity (n)FSGS Morphology (n)Time from Diagnosis to Treatment (mo)Previous IMD (n)Creatinine (mg/dl)eGFR (ml/min per m2)Proteinuria (mg/d)IMD use during ACTH (n)Treatment Regimen (n)
    Complete remission
(n=2)SR: 255 (40–69)M: 1
F: 1WNH: 2Tip: 295 (94–96)2: 1
4: 10.9 (0.6–1.2)82 (71–93)3215 (2100–4330)Yes: 0
No: 2Stanford (1) Columbia (1)
    Partial remission(n=5)SR: 3 SD: 243 (21–64)M: 1
F: 4WNH: 3
BNH:1
BH: 1NOS: 2 Tip: 2 Cellular: 112 (2–56)1: 2
2: 1
3: 21.8 (1.1–3.6)49 (17–76)7849 (5046–15,200)Yes: 2
No: 3Stanford (2)
Columbia (1)
Individual (2)
    Failed (n=17)SR: 9
SD: 5
NA: 344 (18–66)M: 12
F: 5WNH: 8
BNH: 2
WH: 7NOS: 6 Tip: 7 Cellular: 3 Collapsing: 131 (2–132)0: 2
1: 3
2: 5
3: 4
4: 32.1 (0.6–3.4)49 (17–124)3170 (1600–23,800)Yes: 2
No: 15Stanford (9)
Columbia (5)
Individual (3)
    • Values with ranges in parentheses are medians and interquartile ranges. IMD, immunosuppressive therapy; ACTH, adrenocorticotropic hormone; SR, steroid resistant; SD, steroid dependent; M, male; F, female; WNH, white non-Hispanic; BNH: black non-Hispanic; BH, black Hispanic; NOS, not otherwise specified; WH: white Hispanic.

    • View popup
    Table 5.

    Adverse events observed during adrenocorticotropic hormone therapy

    Steroid-like Adverse EventsEvents (n)Patients Experiencing Event (n)
     Swelling/edema/volume overload/weight gain55
     Increased energy44
     Mood alteration/anxiety/increased energy44
     Elevated BP33
     Acne22
     Dyspepsia/bloating22
     Increased appetite11
     Face swelling11
     Hyperglycemia/diabetes (reversible)11
    Other reported adverse events
     Sinus congestion/rhinorrhea/upper respiratory tract symptoms44
     Muscle cramps44
     AKI21
     Pain/bruising at injection site22
     Tanning of skin22
     Rash22
     Fatigue11
     Vertigo11
     Pneumoniaa11
     Slow wound healing11
     Redness of face on injection days11
     Nausea11
     Headache11
     Polyuria11
     Palpitations11
     Intermittent chest discomfort11
     Loose stools11
     Shortness of breath after injection11
    Total events (n)52
    • ↵a Patient 6 was clinically diagnosed with pneumonia and treated empirically with azithromycin. No chest radiography was performed.

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Clinical Journal of the American Society of Nephrology: 8 (12)
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Treatment of Idiopathic FSGS with Adrenocorticotropic Hormone Gel
Jonathan Hogan, Andrew S. Bomback, Kshama Mehta, Pietro A. Canetta, Maya K. Rao, Gerald B. Appel, Jai Radhakrishnan, Richard A. Lafayette
CJASN Dec 2013, 8 (12) 2072-2081; DOI: 10.2215/CJN.02840313

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Treatment of Idiopathic FSGS with Adrenocorticotropic Hormone Gel
Jonathan Hogan, Andrew S. Bomback, Kshama Mehta, Pietro A. Canetta, Maya K. Rao, Gerald B. Appel, Jai Radhakrishnan, Richard A. Lafayette
CJASN Dec 2013, 8 (12) 2072-2081; DOI: 10.2215/CJN.02840313
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