IgA nephropathy is a progressive kidney disease caused by a buildup of the protein immunoglobulin A (IgA) inside the tiny filters, or glomeruli, of your kidneys. The buildup of these deposits can lead to kidney damage and result in the need for dialysis or a kidney transplant. 

To help patients access and take part in the latest research, the IgA Nephropathy (IgAN) Foundation is partnering with pharmaceutical companies to make ongoing clinical trial information available to potential participants. Here are some clinical trials currently seeking to enroll eligible IgAN patients.*

ALN-CC5 IgAN 

The ALN-CC5 trial by Alnylam Pharmaceuticals is testing an experimental medication, called cemdisiran, to see if it can reduce kidney inflammation and decrease the amount of protein leaked by damaged kidneys.

The study involves:

• Observational period with no injections (four to six (4-6) months total) 
• Treatment period of monthly injections (with a two-thirds chance of receiving cemdisiran for nine (9) months total)
• Extended study treatment period during which all participants receive cemdisiran (12 months total)
• Follow-up period consisting of visits every three (3) months, with no injections (12 months total) 

Artemis-IGAN

Sponsored by Omeros Corporation, Artemis-IGAN is a phase III (3) randomized, double-blind, placebo-controlled clinical trial to study the safety and efficacy of the drug narsoplimab. This experimental treatment is used to reduce urine protein excretion at 36 weeks in IgAN patients that are 18 years of age or older. Following screening and evaluation, eligible participants will receive either narsoplimab or a placebo for 12 weeks. 

enVISION 

The enVision clinical trial by Otsuka and Visterra is a phase II (2), double-blind, randomized, placebo-controlled study of approximately 144 patients aged 18 years and older. It is designed to test the safety and tolerability of multiple doses of an experimental treatment, VIS649, and to gauge the effectiveness of different doses by measuring protein levels in urine.

The study consists of three main periods:

• Screening 
• Treatment (12 months)
• Follow-up (four (4) months)

NefIgArd  

Calliditas Therapeutics has full enrollment for the NefIgArd study, a phase III (3) randomized, double-blind, placebo-controlled study to evaluate the efficacy of an investigational drug, called nefecon. Nefecon is a new oral formulation of budesonide designed to be delivered to a specific part of the intestines, where the majority of the immune cells that produce IgA are located. 

• During Part A, participants will be given capsules to swallow by mouth once daily for nine (9) months.
• All participants will continue to Part B, an observational long-term follow-up to monitor renal function. No investigational drugs will be administered during this period.

PROTECT 

Sponsored by Travere Therapeutics (previously known as Retrophin), the PROTECT study is a global phase III (3) clinical trial. This trial will determine if an investigational study drug, called sparsentan, can reduce proteinuria and slow kidney function decline in patients with IgAN and patients with focal segmental glomerulosclerosis (FSGS). 

PROTECT seeks to enroll 380 participants at 170 locations worldwide for the 27-month study. No placebos will be used. Participants will receive either sparsentan or a different drug, called irbesartan, commonly used to treat IgAN.  

ALIGN 

Sponsored by Chinook Therapeutics, the ALIGN Study will investigate an experimental medication, called atrasentan, to reduce protein in the urine and preserve kidney function in IgAN patients. Atrasentan has already been tested on over 5,000 patients with diabetic kidney disease—and with successful outcomes—but this is the first time the study will be tested on IgAN. 

The study is recruiting approximately 320 patients with IgAN throughout North America, South America, Europe, and Asia-Pacific. Enrollees must be 18 years old and have an IgAN diagnosis confirmed by a kidney biopsy. 

ADL-CU-19

Another study sponsored by Chinook Therapeutics, the ADL-CU-19 phase I (1), multi-center clinical trial is testing an experimental drug, called BION-1301. The trial is specifically testing the medication’s pharmacokinetics (movement through the body) and pharmacodynamics (effects and mechanism of the drug’s action) on both patients with IgAN and healthy volunteers. Participant enrollment begins in early 2021.

Learn more about clinical trial eligibility requirements on the IgAN Foundation website.

*IgA Nephropathy Foundation. (2020, Nov. 12). Clinical Trials for IgAN. https://igan.org/clinical-trials/