Trial · Interventional

CompletedPhase 4Results postedRegistry data

Treatment of Resistant Nephrotic Syndrome With ACTH Gel (ACTHAR)

NCTNCT01129284Other idAAAD9539

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names ACTH (corticotropin), does not test it. It appears in the title.

Overview

Status: Completed
Phase: Phase 4
Enrollment: 15 participants (actual)
Sponsor: Columbia University · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Dec 2009
Primary completion: Sept 2011
Completion: Sept 2011
First posted: 24 May 2010 (estimated)
Last update posted: 24 Apr 2014 (estimated)
Conditions: Treatment Resistant Nephrotic Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2009201020112012

Ph 4
Treatment of Resistant Nephrotic Syndrome With ACTH Gel (ACTHAR)
NCT01129284
Dec 2009 to Sept 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study will examine the safety and effectiveness of ACTHAR Gel, when used to treat 15 patients diagnosed with "treatment resistant nephrotic syndrome." Nephrotic syndrome is a group of symptoms that includes low levels of protein in the blood, swelling of tissue (edema), especially around the eyes, feet and hands; and high plasma levels of cholesterol. It is caused by a variety of diseases and underlying disorders that damage the kidneys, resulting in excessive excretion of protein in the urine. These diseases damage the glomeruli, which are small blood vessels that filter wastes and excess water from the blood and pass them into the bladder as urine. As a result of protein loss in the urine, the blood is deficient in protein. Normal amounts of blood protein are needed to help regulate fluid throughout the body. Protein in the blood normally draws water from the tissues and into the bloodstream. When blood protein levels are low, the normal movement of water is reversed, and fluid is drawn from the blood and accumulates in the tissues. This excess tissue fluid causes the swelling and puffiness (edema) that is a symptom of nephrotic syndrome. Nephrotic syndrome is described as "treatment resistant" when a patient fails to achieve a sustained partial or complete remission after treatment with at least two first line therapies. The goal of this study is to determine whether injections of ACTHAR Gel (an FDA approved treatment for nephrotic syndrome) over a six month period will lead to a correction of treatment resistant nephrotic syndrome in these patients.

Interventions

ACTHAR gelDrug

Arms1

Experimental
Acthar gel
Patients will be treated with ACTHAR gel starting with 40 units given twice weekly subcutaneously for two weeks, then 80 units given twice weekly subcutaneously afterwards for a period of up to six months.

Primary outcomes1

Outcomes the sponsor listed as primary.

Significant Reduction in Proteinuria to Remission Levels During the Treatment Period (Includes Complete and Partial Remission, as Defined in the Outcome Measure Description Below)
Time frame · 6 months
Registry description
Complete remission is defined as stable or improved renal function, serum creatinine \< or = 125% baseline, with proteinuria falling \<500 mg/day at month 6. Partial remission is defined as stable or improved renal function, serum creatinine \< or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at month 6.

Secondary outcomes(1)

Sustained Remissions up to 1 Year After Discontinuing Therapy
Time frame · Up to 1 year after treatment
Registry description
Complete remission defined as stable or improved renal function, serum creatinine \< or = 125% baseline, with proteinuria falling \<500 mg/day at last follow-up visit (6 to 12 months post treatment). Partial remission defined as stable or improved renal function, serum creatinine \< or = 125% baseline, with 50% reduction in proteinuria and final proteinuria 500-3500 mg/day at last follow-up visit (6 to 12 months post treatment).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 6 months

Significant Reduction in Proteinuria to Remission Levels During the Treatment Period (Includes Complete and Partial Remission, as Defined in the Outcome Measure Description Below)

Group	Value (participants)
Membranous Nephropathy	2
FSGS/MCD	2
IgA Nephropathy	3

Secondary and other outcome results(1)

Secondary outcomeNumber· Up to 1 year after treatment

Sustained Remissions up to 1 Year After Discontinuing Therapy

Group	Value (participants)
Membranous Nephropathy	3
FSGS/MCD	2
IgA Nephropathy	2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Membranous NephropathySubjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months	–	2 / 5	1 / 5
FSGS/MCDSubjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months	–	0 / 5	1 / 5
IgA NephropathySubjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months	–	0 / 5	1 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

Indexing hint: Clinical trial · 2013

Treatment of idiopathic FSGS with adrenocorticotropic hormone gel.

Hogan et al. 2013Clinical journal of the American Society of Nephrology : CJASNcited by 68

PMID 24009220PMC3848392DOI 10.2215/cjn.02840313PUB-24009220

Rights unknown

Source link

Indexing hint: Clinical trial · 2012

Treatment of resistant glomerular diseases with adrenocorticotropic hormone gel: a prospective trial.

Bomback et al. 2012American journal of nephrologycited by 64

PMID 22722778DOI 10.1159/000339287PUB-22722778

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Adult nephrotic patients, at least 18 years of age 2. Diagnosis of focal segmental glomerulosclerosis (FSGS), resistant or relapsing minimal change disease with failure to achieve a sustained partial or complete remission of the nephrotic syndrome after therapy with at least two first line therapies: corticosteroids and at least one other immunosuppressive regimen 3. Diagnosis of membranous nephropathy with failure to achieve a sustained partial or complete remission of the nephrotic syndrome after therapy with at least two first line therapies: either the "Ponticelli protocol" of alternating months of pulse steroids followed by oral steroids and then an alkylating agent with each regimen repeated for six full months of therapy or a calcineurin inhibitor, cyclosporine or tacrolimus, and at least one other therapy 4. Diagnosis of immunoglobulin A nephropathy (IgAN) with persistent nephrotic range proteinuria in patients on ACE inhibition or angiotension receptor blockers (ARB) therapy to reduce proteinuria 5. Willing and able to sign informed consent 6. Patients of childbearing age must agree to use birth control Exclusion Criteria: 1. Patients under 18 years of age 2. Patients unable to sign informed consent 3. Patients having received rituximab or another monoclonal antibody within 6 months of the trial 4. Patients of childbearing age who refuse to use birth control 5. Patients with an estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2 6. Patients with other renal diseases (e.g. diabetic nephropathy, renal vascular disease) that would interfere with interpretation of the study. 7. Patients with comorbid conditions that would interfere with completion of the trial (malignancies, congestive heart failure (CHF), recent myocardial infarction). 8. Patients with known contraindications to the use of H.P. ACTHAR Gel, including: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, and allergies to pork or pork products.

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