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SuspendedNCT03042637Updated Feb 17, 2021

Safety and Efficacy of Combination Acthar Gel and Tacrolimus in the Treatment of Steroid Resistant Nephrotic Syndrome

An observational study in Nephrotic Syndrome, sponsored by Southeast Renal Research Institute. Suspended at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-02-17.

Sponsored by Southeast Renal Research Institute · Observational

Why this study was suspended
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Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Ages
18 Years to 80 Years
Sex
All
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Study summary

The management of steroid-resistant nephrotic syndrome (SRNS) remains a persistent problem for investigators in part because of the wide array of pathogenic cccccccccc mechanisms that contribute to these disorders as well as the lack ofs. While glucocorticoids remain the primary therapy for many forms of protein uric glomerularxxxxxxxxx diseases, prolonged use is associated with significant morbidities including steroid induced diabetes, metabolic bone disease, and excessive weight gain.

Read the detailed description

Multiple agents have been investigated in the treatment of patients with SRNS, but there is no consensus on what constitutes optimal therapy. Previous studiesoids and have shown complete and partial response rates between 40% and 60%. More recently, calcineurin inhibitors (CNI) have become an effective second line therapy with similar response rates between 50%-70%. However, both treatment regiments are limited by the risk for infection as well as the development of vvvvvvv CNI-induced nephrotoxicity and progressive renal disease. Acthar gel is a porcine pituitary preparation composed of ACTH and for treatment of idiopathic nephrotic syndrome. Previous studies, as well as more current studies, have shown that ACTHar gel can effectively reduce proteinuriammmmmmmm in idiopathic membranous glomerulonephritis and other forms of glomerulopathy including focal segmental glomerulosclerosis (FSGS) and advanced diabetic nephropathy. While the mechanism is unknown, previous studies have shown that melanocortin 1-receptors are expressed in glomerular podocytes and thatpathway could be involved in the protein lowering effects of ACTHar bbbbbbbbgel. Incubation of cultured podocytes with ACTH leads to activation of MCR-1 receptors and the subsequent stimulation of protein kinase A (PKA) through a G-protein-dependent pathway. The downstream phosphorylation and stabilization of Rho GTPases, synaptopodin and other cell-cytoskeletal associated proteins may stabilize podocyte function and density.

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Conditions studied

  • Nephrotic Syndrome
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In context

Nephrotic Syndrome

192 studies on the registry are indexed under Nephrotic Syndrome; 63 are open to participants now.

Browse Nephrotic Syndrome studies →

Lead sponsor

Southeast Renal Research Institute is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients between the ages of 18 and 80 with refractory nephrotic syndrome secondary to Type I or Type II diabetes

Inclusion criteria

  • refractory nephrotic syndrome secondary, defined as subjects having a urine protein/Cr ratio over 3.0 while actively receiving ACE inhibitors and hyperglycemic therapy (i.e., insulin or oral hyperglycemic agents).
  • Type I or Type II diabetes
  • receiving combination therapy with an ACE inhibitor and a second protein lowering agent (e.g., ARB, non dihydropyridine CCB, or spironolactone).

Exclusion criteria

Exclusion Criteria:

  • known primary or secondary membranous glomerulonephritis (GN)
  • primary or secondary focal segmental glomerulosclerosis
  • other nondiabetic forms of glomerulopathy
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Patient registry
No

Groups and cohorts

  • Acthar Gel and Tacrolimus

    Combination therapy with Acthar Gel and Tacrolimus

    Drug: Acthar Gel and Tacrolimus

Interventions

  • DrugActhar Gel and Tacrolimus

    Combination therapy with Acthar Gel and Tacrolimus (0.5-3.0 mg BID) following 6 months of ACTH therapy only

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What researchers measure

Primary outcomes

  1. Reduction of proteinuria in idiopathic membranous glomerulonephritis (MGN) and other forms of glomerulopathy including focal segmental glomerulosclerosis (FSGS) and advanced diabetic nephropathy

    Subjects with steroid resistant nephrotic syndrome were treated with sub-cutaneous (SQ) ACTHar gel, (40-80 units) SQ 2X-3X/week. After 6 months of ACTHar gel therapy subjects achieving complete remission were weaned off therapy over a 3-12 month period.

    Time frame: 6 months

Secondary outcomes

  1. Partial remission or no response to treatment regiment

    Subjects exhibiting no response or partial remission were maintained on existing ACTHar gel doses and started on oral Tacrolimus (0.03 to 0.06 mg/kg/day) titrating to a trough level of 5-10 ng/ml for an additional 6 months.

    Time frame: 6 months

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Study locations

1 site
  • Nephronet
    Chattanooga, Tennessee 37408, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03042637
Lead sponsor
Southeast Renal Research Institute
Responsible party
James A. Tumlin MD (Principal Investigator, Southeast Renal Research Institute) — Principal investigator
First posted
Feb 3, 2017
Start date
Jan 2012
Primary completion
Dec 2016
Completion
Dec 2021 (estimated)
Last update
Feb 17, 2021

Study contacts

James A Tumlin, MD
principal investigator · NephroNet Clinical Research Consortium

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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