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CLINICAL TRIALS

The IgA Nephropathy Foundation is working with the partners below to provide our patients access to breakthrough clinical trials. Patient participation is the key to finding treatment and the ultimate cure for IgA Nephropathy. Read more about each trial below to see if you are eligible.

The ALIGN Study: The ALIGN Study is testing an investigational medication called atrasentan that has the potential to reduce the amount of protein in urine and preserve kidney function in patients with IgA nephropathy. 

Learn more and see if you are eligible www.alignstudy.com

ALN-CC5 IgAN Trial: The ALN-CC5 IgAN trial is researching an investigational medication called cemdisiran (cem-DEE-si-ran). In people with IgAN, a protein called IgA builds up in the kidney causing inflammation. This may lead to kidney damage that causes protein from the blood to leak into urine.

2020-10-02

ADU-CL-19 Trial is a Phase 1, Multicenter Trial to Investigate the Safety, Tolerability, pharmacokinetics and pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy. The primary objective of the trial is to assess the safety, pharmacokinetics and pharmacodynamics of BION-1301 in healthy volunteers and patients with IgAN.

APPLAUSE-IgAN is a Phase 3 global clinical trial that will look at the effects of an investigational drug, iptacopan (LNP023), in people with IgAN. The trial will study the effects of iptacopan (LNP023) on reducing inflammation and kidney damage in people with IgAN.

Artemis-IGAN Clinical Trial: Omeros Corporation is sponsoring the ARTEMIS-IGAN clinical trial, a randomized, double-blind, placebo-controlled, Phase 3 study of the safety and efficacy of narsoplimab in patients with immunoglobulin A (IgA) nephropathy.

EPPIK clinical study for children with rare kidney diseases is now enrolling. Your child may be eligible to participate in the EPPIK Study if your child:

• Is between 1-17 years of age living in the US, UK and several countries in Europe

• Has been diagnosed with FSGS, IgAN, IgAV, MCD or Alport syndrome

• Is not on dialysis and has not had a transplant

Talk with your doctor and family members about joining the EPPIK Study.

Sites are open and currently recruiting.

Travere Therapeutics is now enrolling children ages 1 to 17 years with rare kidney diseases in the EPPIK clinical study. The EPPIK study will evaluate the investigational drug, sparsentan, for the treatment of selected rare kidney diseases. Kidneys are important organs that filter waste products from blood into the urine. The rare kidney diseases included in the EPPIK study are characterized by gradual loss of kidney function and increased protein in the urine (proteinuria).

Proteinuria is seen as a marker of kidney function and lowering its level is associated with slowing down the loss of kidney function and better kidney outcomes. Our investigational approach is to lower proteinuria levels with sparsentan and slow the loss of kidney function in children with:

• Focal segmental glomerulosclerosis (FSGS)

• Minimal change disease (MCD)

• IgA nephropathy (IgAN), also known as Berger’s disease

• IgA vasculitis (IgAV), also known as Henoch-Schönlein purpura

• Alport syndrome (AS)

Currently, treatment options are limited and there are no approved treatment options for children with these conditions.

The study is open-label, which means all study participants will be receiving

sparsentan, and you and your child will always know how much of the

investigational drug your child is receiving.

For more information please click on the read more button below.

FREEDOM-1 Study: If you plan to receive a kidney transplant from a living donor, you may be eligible to participate in the FREEDOM-1 Study. The study is evaluating an investigational treatment that could potentially eliminate the need for anti-rejection drugs among living donor kidney transplant recipients.

 Learn more at https://freedom1study.com

NefIgArd Study: Calliditas Therapeutics is sponsoring the NefIgArd study, a randomized, double-blind and placebo-controlled Phase 3 study for IgA nephropathy. We will enroll up to 360 participants in the NefIgArd study.

FULLY ENROLLED

The phase 2 IGNAZ Trial: Are you or someone you know diagnosed with IgA Nephropathy (IgAN) and interested in learning more about a clinical trial with an investigational treatment option for IgAN which was designed to reduce unwanted auto-antibodies responsible for the development of IgAN? If yes, please send an email to MorphosysCTHotline@druginfo.com and provide the country, city or state and zip code of your location along with your contact phone number and/or email address. Your information will then be forwarded to a study site close to your place of living, who will reach out to you for evaluation of your eligibility for participation.

****Fully Enrolled

Phase 2 RC18 IgAN Study: is seeking volunteers for participation in this study evaluating an investigational new drug to determine if it can treat IgAN. A clinical study using this investigational new drug in China showed potential benefits in treating IgAN by reducing urine protein. However, more clinical data is needed to further evaluate the effectiveness and safety of Telitacicept in IgAN patients.

If you or a loved one have been diagnosed with IgA Nephropathy (IgAN) and are interested in exploring the option of clinical trial participation, send an email to RC18_IGANstudy@remegenbio.com with your name, phone and zip code. Your contact information will be shared with the nearest study site who can answer all of your questions and help to determine if you are eligible to participate in the study. 

Now Enrolling People with Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN) For A Research Study

Phase 2 ALXN1210-NEPH-202 Study (clinicaltrials.gov NCT04564339)

Purpose of Study:

The purpose of this clinical trial is to evaluate the safety and efficacy (effectiveness against disease) of the study medication (ALXN1210 also known as ravulizumab or ULTOMIRIS ®) in participants with lupus nephritis (LN) or immunoglobulin A nephropathy (IgAN), a rare chronic kidney disease.

Learn more by visiting https://www.clinicaltrials.gov/ct2/show/NCT04564339 or call Alexion at 855-752-2356 or email clinicaltrials@alexion.com.

Phase 3 Protect Study: Retrophin is now enrolling patients in the PROTECT Study, a global Phase 3 clinical research study, to determine whether sparsentan can reduce the amount of protein in the urine and slow down the decline of kidney function in patients with IgAN.

FULLY ENROLLED

VT-001-0050 ORIGIN Trial: The ORIGIN trial is researching an investigatial medication called ataceipt in people with IgAN.  The goal of the study is to measure the effectiveness of the study medication at improving kidney function by preventing damage caused from inflammation due to the build up of IgA.

VISIONARY: A Phase 3 clinical trial of sibeprenlimab for adults with IgA Nephropathy. Targeting a brighter future for IgAN patients.

Now Enrolling – To find out more information on the trial, visit our website at visionarystudy.com Thanks,

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