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Study · Non-randomized trial · n = 19 · 2025

4 results

Efficacy of Acthar gel and Tacrolimus in DNA-JB9 Positive Fibrillary Glomerulopathy.

Tumlin JA, Podoll A, Kopyt N, Rovin B, Lafayette R, Bomback A, Glassock R, Whitson J, Press A, Appel GB

Kidney international reports30 Jun 2025Cited by 1 (Europe PMC)

PMID40980649 (opens in a new tab)PMCIDPMC12446950 (opens in a new tab)DOI10.1016/j.ekir.2025.06.042 (opens in a new tab)PepBankPUB-40980649
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Summary

IntroductionFibrillary glomerulopathy (FGN) is a rare glomerular disease characterized by the deposition of randomly arranged fibrils that results in proteinuria and end-stage renal disease (ESRD) in up to 50% of patients within 2 years. The FACT trial is a prospective, randomized, open-labeled study of patients with biopsy-proven, DNA-JB9 positive FGN comparing the safety and efficacy of repository corticotropin (ACTH) injection, Acthar gel alone or in combination with tacrolimus on proteinuria and change in estimated glomerular filtration rate (eGFR).MethodsPatients (N = 34) were randomized to ACTH 80 units subcutaneous 2×/wk alone or in combination with tacrolimus (1.0 mg 2×/d) for 12 months. Changes in the mean urinary protein-to-creatinine ratio (UPCR) and eGFR were reported at 6 and 12 months and last follow-up.ResultsA total of 34 patients completing 1 year of therapy were analyzed. In the ACTH-alone group (19 patients), UPCR decreased from a mean of 6.21 ± 0.8 g/g at baseline to 2.92 ± 0.90 g/g (P P < 0.02) at month 12. In the combination group (15 patients), mean UPCR decreased significantly from 6.00 ± 1.4 g/g at baseline to 4.27 ± 1.1 g/g (P P < 0.0006) at 6 and 12 months, respectively. At 12 months, combination therapy induced complete or partial responses in 13.3% and 53.3% compared with 15.8% and 26.3% in the ACTH alone group, respectively.ConclusionRepository ACTH (Acthar gel) significantly reduced UPCR at 6 and 12 months. The addition of tacrolimus was not additive with ACTH in reducing proteinuria or stabilization of eGFR. Acthar gel is an effective antiproteinuric therapy for DNA-JB9 positive FGN.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In patients with FGN receiving Acthar alone, mean UPCR decreased from 6.21 to 2.92 g/g at 6 months.

    In plain wordsIn patients with FGN, Acthar alone reduced urine protein compared with baseline at 6 months.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseUPCR at 6 months
    Study

    n = 19

    Comparator
    Baseline
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    80 units twice weekly · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    UPCR
    6.21 g/g
    baseline, Acthar alone
    UPCR reported variability
    0.8 g/g
    baseline, Acthar alone; variability type unspecified
    UPCR
    2.92 g/g
    6 months, Acthar alone
    UPCR reported variability
    0.9 g/g
    6 months, Acthar alone; variability type unspecified
    P
    < 0.009
    6 months versus baseline

    Source sentences

    Summary
    In the ACTH-alone group (19 patients), UPCR decreased from a mean of 6.21 ± 0.8 g/g at baseline to 2.92 ± 0.90 g/g (P P < 0.02) at month 12.
    1 context sentence
    Summary · context
    Patients (N = 34) were randomized to ACTH 80 units subcutaneous 2×/wk alone or in combination with tacrolimus (1.0 mg 2×/d) for 12 months.
  2. 02HumanNon-randomized trialEfficacy outcome

    In patients with FGN receiving Acthar alone, mean UPCR decreased from 6.21 to 1.76 g/g at month 12.

    In plain wordsIn patients with FGN, Acthar alone reduced urine protein compared with baseline at month 12.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseUPCR at 12 months
    Study

    n = 19

    Comparator
    Baseline
    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    80 units twice weekly · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    UPCR
    6.21 g/g
    baseline, Acthar alone
    UPCR reported variability
    0.8 g/g
    baseline, Acthar alone; variability type unspecified
    UPCR
    1.76 g/g
    12 months, Acthar alone
    UPCR reported variability
    1.3 g/g
    12 months, Acthar alone; variability type unspecified
    P
    < 0.02
    12 months versus baseline

    Source sentences

    Summary
    In the ACTH-alone group (19 patients), UPCR decreased from a mean of 6.21 ± 0.8 g/g at baseline to 2.92 ± 0.90 g/g (P P < 0.02) at month 12.
    1 context sentence
    Summary · context
    Patients (N = 34) were randomized to ACTH 80 units subcutaneous 2×/wk alone or in combination with tacrolimus (1.0 mg 2×/d) for 12 months.
  3. 03HumanNon-randomized trialEfficacy outcome

    In patients with FGN receiving Acthar alone, the complete response proportion was 15.8% at 12 months.

    In plain wordsIn patients with FGN, 15.8% had a complete response with Acthar alone at 12 months.

    Peptide
    ACTH (corticotropin)
    Outcome
    Not applicableComplete response at 12 months
    Study

    n = 19

    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    80 units twice weekly · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Complete response proportion
    15.8%
    12 months, Acthar alone

    Source sentences

    Summary
    At 12 months, combination therapy induced complete or partial responses in 13.3% and 53.3% compared with 15.8% and 26.3% in the ACTH alone group, respectively.
    1 context sentence
    Summary · context
    Patients (N = 34) were randomized to ACTH 80 units subcutaneous 2×/wk alone or in combination with tacrolimus (1.0 mg 2×/d) for 12 months.
  4. 04HumanNon-randomized trialEfficacy outcome

    In patients with FGN receiving Acthar alone, the partial response proportion was 26.3% at 12 months.

    In plain wordsIn patients with FGN, 26.3% had a partial response with Acthar alone at 12 months.

    Peptide
    ACTH (corticotropin)
    Outcome
    Not applicablePartial response at 12 months
    Study

    n = 19

    Outcome group
    Kidney function · Kidney and urinary
    Studied dose
    80 units twice weekly · subcutaneous · 12 monthsAs given in this study (human).

    Measurements

    Partial response proportion
    26.3%
    12 months, Acthar alone

    Source sentences

    Summary
    At 12 months, combination therapy induced complete or partial responses in 13.3% and 53.3% compared with 15.8% and 26.3% in the ACTH alone group, respectively.
    1 context sentence
    Summary · context
    Patients (N = 34) were randomized to ACTH 80 units subcutaneous 2×/wk alone or in combination with tacrolimus (1.0 mg 2×/d) for 12 months.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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