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The ALIGN Study

See all Clinical Trials


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.

Approximately 320 patients across North America, South America, Europe, and Asia-Pacific with IgA nephropathy will participate in the ALIGN study. Patients will be randomly assigned to receive atrasentan or placebo daily for 132 weeks and will also receive a maximally-tolerated and stable dose of a RAS (renin-angiotensin system) inhibitor (such as angiotensin converting enzyme inhibitor (ACEi) or angiotensin-receptor antagonist (ARB)) as part of standard of care. Subjects who are unable to tolerate RAS inhibitor therapy will also be eligible to participate.

The ALIGN study will evaluate if atrasentan can reduce how much protein is in your urine and delay the worsening of kidney function. The study will also evaluate the safety and tolerability, as well as quality of life.

Patients will have assessments of safety and efficacy over 2 ½ years. To facilitate study participation over this period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.
Patients who complete the study may be eligible to enroll in an extension study to receive open-label treatment with atrasentan under a separate protocol.

The ALIGN study will begin enrolling at clinical sites across the globe in early 2021. To see if you may qualify and find a clinical site near you see www.alignstudy.com and NCT04573478


The ADU-CL-19 Study

Chinook Therapeutics, ADU-CL-19 Short Summary — IGAN Foundation of America

Chinook Therapeutics, Inc. is developing BION-1301,an investigational IgG4 humanized monoclonal antibody that blocks A Proliferation-Inducing Ligand, or APRIL. Studies have shown high levels of APRIL correlate with poor prognoses in patients with IgA nephropathy (IgAN), a chronic autoimmune kidney disease.

ADU-CL-19 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.

In Part 3 of the trial, patients with IgAN will be randomized into two cohorts receiving BION-1301 at differing doses and frequency in an open-label manner. Enrolled patients will receive three months of dosing with BION-1301 (IV formulation) and three months of follow-up. The trial duration is expected to be 24 weeks with sites in both the US and UK. Patients enrolled in Part 3 of the study may be eligible to continue dosing for up to 24 months through participation in an Open Label Extension study the sponsor is opening.

If you are an adult patient with IgAN who meets these eligibility criteria and are interested in participating in this study, additional information may be found on ClinicalTrials.gov (Identifier: NCT03945318) and https://www.chinooktx.com/patients/iga-nephropathy/.

Chinook IgAN ADU-CL-19 Poster

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May 14, Sunday: Mother’s Day & IgA Nephropathy Awareness Day

The IgAN Foundation was sparked by a mother’s love and has grown into a community sharing crucial resources and working toward a cure. This day kicks off a week of celebrating the IGA Nephropathy family all week!

May 15, Monday: Mindfulness

IgA Nephropathy can be challenging and mindfulness is an important part of caring for yourself. Take a moment today and implement a mindfulness practice, meditate, or take a few moments in reflection to check in with yourself.

May 16, Tuesday: Share Your Story

On this day, the Foundation will share the video with Warrior stories compiled (submit yours here if you haven’t yet). We encourage you to also share your own photos and videos from moments along your journey!

May 17, Wednesday: Wellness

What are you doing to feel well today? IgA Nephropathy can sometimes make life feel uncontrollable, but there are some things we can control, for example:

  • Enjoyable movement (a stretch, a walk, dancing to a favorite song)
  • Eating food that’s right for us individually
  • Checking in with ourselves
  • Meditating

May 18, Thursday: Thank those who care

Between care teams, care partners, and medical providers, a lot goes into the care that sustains us as we live with IgA Nephropathy. Take this opportunity to express your appreciation to them!

May 19, Saturday: Rally cry

When the IgA Nephropathy Foundation was created, there were no resources to treat IgA Nephropathy. Now, there are 2 approved FDA treatments and many clinical trials in the works. Our community is strong and full of hope— here’s to even more progress in the future!

May 20, Saturday: Celebration! 

We’ll be hosting an in-person celebration (details to come). We’ll miss you if you can’t make it, but please take the time to celebrate however works for you — wearing your IgAN Foundation sunglasses, spending time with loved ones, etc. — just be sure to share a photo and tag us!

References

  • Hall, Y.N., Fuentes, E.F., Chertow, G.M. et al. Race/ethnicity and disease severity in IgA nephropathy. BMC Nephrol 5, 10 (2004). https://doi.org/10.1186/1471-2369-5-10
  • Kiryluk K, Li Y, Sanna-Cherchi S, Rohanizadegan M, Suzuki H, et al. (2012) Geographic Differences in Genetic Susceptibility to IgA Nephropathy: GWAS Replication Study and Geospatial Risk Analysis. PLoS Genet 8(6): e1002765. doi:10.1371/journal.pgen.1002765