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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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This study is designed to answer whether patients with progressive IgA nephropathy, who receive Acthar (ACTH) gel injection at a dose of 80 units subcutaneously twice weekly for 6 months is effective in inducing improvement in proteinuria and renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACTH Gel | Experimental | Injected does of 80 units subcutaneously twice weekly for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACTH (Acthar) Gel | Drug | Injected dose of 80 units subcutaneously twice weekly for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a Complete or Partial Response to Treatment | A complete response is defined by <300 mg proteinuria/24 hours and no greater than a 10% reduction in glomerular filtration rate (GFR) as determined by quantified creatinine clearance. A partial response is defined by >50% reduction in 24 hour proteinuria and no greater than a 25% reduction in baseline GFR as quantified creatinine clearance. No response is defined by < or equal to 50% reduction, unchanged or increasing proteinuria over baseline levels and a greater than a 25% reduction in baseline GFR as quantified creatinine clearance. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects to Develop an Infection | The number of subjects with infections was defined as the development of pneumonia or complicated urinary tract infection/Pyelonephritis | 12 months |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Fervenza, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| Mayo Clinic Jacksonville |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acthar (ACTH) Gel | Injected does of 80 units subcutaneously twice weekly for 6 months. Acthar (ACTH) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACTH Gel | Injected does of 80 units subcutaneously twice weekly for 6 months. ACTH (Acthar) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With a Complete or Partial Response to Treatment | A complete response is defined by <300 mg proteinuria/24 hours and no greater than a 10% reduction in glomerular filtration rate (GFR) as determined by quantified creatinine clearance. A partial response is defined by >50% reduction in 24 hour proteinuria and no greater than a 25% reduction in baseline GFR as quantified creatinine clearance. No response is defined by < or equal to 50% reduction, unchanged or increasing proteinuria over baseline levels and a greater than a 25% reduction in baseline GFR as quantified creatinine clearance. | Posted | Count of Participants | Participants | 12 Months |
|
Adverse events will be collected from baseline until the completion of the final study visit for each subject, approximately 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACTH Gel | Injected does of 80 units subcutaneously twice weekly for 6 months. ACTH (Acthar) Gel: Injected dose of 80 units subcutaneously twice weekly for 6 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fernando Fervenza | Mayo Clinic | 507-266-1045 | fervenza.fernando@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2015 | Jun 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011507 | Proteinuria |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| D005782 | Gels |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Subjects to Develop an Infection | The number of subjects with infections was defined as the development of pneumonia or complicated urinary tract infection/Pyelonephritis | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 10 |
| 19 |
| Acne | General disorders | Systematic Assessment |
|
| Hot flashes | General disorders | Systematic Assessment |
|
| Soreness | General disorders | Systematic Assessment |
|
| Anxiety | General disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |