Acthar on Proteinuria in IgA Nephropathy Patients

What Was Tested

The trial (phase 4) is built around ACTH (Corticotropin).

IgA nephropathy occurs when IgA-a protein that helps the body fight infections-settles in the kidneys.

IgA deposits may cause the kidneys to leak blood and sometimes protein in the urine.

Proteinuria (abnormal amounts of protein in urine) can be a sign of kidney damage.

It had two arms (groups): Acthar injection 2 times per week (experimental) and Acthar injection 3 times per week (experimental).

The registry classes the interventions as drug.

More on the Plan

Participation in this study may last up to 2 years (from first visit to final visit) and includes 10 study visits and 8 phone calls.

If they are already on another ACEI, Lisinopril will be prescribed.

If subjects are unable to tolerate Lisinopril or other ACEI medications, an angiotensin receptor blocker (ARB) will be prescribed.

ARBs are another type of medication that also helps relax blood vessels if subjects cannot tolerate ACEI medications.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed informed consent prior to any study specific procedures. Male and females aged 18 years and older. BMI 40 kg/m2 or less. History of nephrotic syndrome due to IgA (confirmed from renal biopsy performed within last 5 years). Antihypertensive treatment including use of Angiotensin-converting enzyme inhibitors (ACEI) and/or Angiotensin receptor blockers (ARB):.

The full record lists 21 inclusion and 38 exclusion criteria; among the exclusions: inability or refusal to give informed consent; unwillingness to receive or intolerant of sc injections of study medication; use of disease modifying agent within "delayed effect" 1 month of visit 1 with: glucorticoids, cyclophosphamide, cyclosporine, cellcept.

How the Study Was Run

It was run as a randomized, single-group and open-label study.

Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Being open-label, the ACTH (Corticotropin) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2015-02 with completion listed for 2019-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To assess final protein/creatinine ratio (time frame: 12 months).

It also tracked 10 secondary outcomes, for example Number of Inflammatory cells- change from baseline to 12 months to assess final kidney histology and disease activity index, IgA level - change from baseline to 12 months to assess final kidney histology, disease activity index, and disease status, Amount of sclerosed glomeruli - change from baseline to 12 months to assess final kidney histology and disease activity index, Serum Creatinine - change from baseline to 2 years to assess disease status, Albumin - change from baseline to 2 years to assess disease status and Aldosterone - change from baseline to 2 years to assess disease status.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, all human trials.