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

NCT03042637 | Suspended DMC

• 1 other identifier: 12345
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrotic Syndrome

Outcome Measures

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.

  6 months

Secondary Outcomes (1)

• Partial remission or no response to treatment regiment

  6 months

Study Arms (1)

Acthar Gel and Tacrolimus

Combination therapy with Acthar Gel and Tacrolimus

Drug: Acthar Gel and Tacrolimus

Interventions

Acthar Gel and Tacrolimus DRUG

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

Acthar Gel and Tacrolimus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Southeast Renal Research Institute: lead

Study Sites (1)

Nephronet

Chattanooga, Tennessee, 37408, United States

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• James A Tumlin, MD

  NephroNet Clinical Research Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: February 3, 2017
• Study Start: January 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2021
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)