TARPEYO® for Immunoglobulin A Nephropathy

(NefXtend Trial)

Recruiting at 30 trial locations

Overseen By Annette LeBlanc-Donahue

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Calliditas Therapeutics AB

Must be taking: TARPEYO, RAS inhibitors

Must not be taking: Systemic immunosuppressives, CYP3A4 inhibitors

Disqualifiers: Other glomerulopathies, Nephrotic syndrome, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 15 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether extended use of TARPEYO®, a delayed-release medication, is effective and safe for adults with primary IgA nephropathy, a kidney disease that causes inflammation and damage. Participants will continue TARPEYO® treatment after an initial 9-month period to determine if longer treatment provides additional benefits. The trial includes regular urine and blood tests, along with physical exams. Suitable candidates for this study have completed 9 months of TARPEYO® treatment, have biopsy-confirmed IgA nephropathy, and are managing their condition with stable medications. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that participants stay on a stable dose of renin-angiotensin system (RAS) inhibitors and sodium-glucose cotransporter-2 (SGLT2) inhibitors if they are already taking them. However, you cannot take systemic immunosuppressive medications other than TARPEYO® during the trial.

What is the safety track record for TARPEYO®?

Research has shown that TARPEYO® treats adults with IgA nephropathy, a kidney disease. Studies have found that it can help lower protein levels in urine, which indicates improved kidney health.

The FDA has approved TARPEYO® for this condition, confirming its safety for many people. Previous patients have used this treatment without major safety issues.

Some side effects, such as high blood pressure, headache, and stomach pain, have been reported. However, these are usually mild and manageable. Monitoring any side effects and discussing them with the study team is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about TARPEYO® for treating Immunoglobulin A Nephropathy because it offers a unique approach compared to current options. Most treatments for this condition, like steroids and immunosuppressants, mainly aim to control inflammation and slow kidney damage. TARPEYO® works differently by specifically targeting the gut-associated lymphoid tissue, which is believed to play a crucial role in the disease's progression. This targeted action could potentially reduce side effects and improve kidney function more effectively, making it a promising alternative for patients.

What is the effectiveness track record for TARPEYO® in treating IgA nephropathy?

Research has shown that TARPEYO® can slow the decline in kidney function in adults with primary immunoglobulin A nephropathy (IgAN). Studies have found that patients taking TARPEYO® improved in key kidney health indicators, such as protein levels in urine and kidney filtration efficiency. These findings suggest that TARPEYO® helps prevent further kidney damage in individuals with worsening IgAN. TARPEYO® is already approved for treating IgAN, highlighting its proven effectiveness for this condition. ^{6 7 8 9 10}

Who Is on the Research Team?

Krassimir Mitchev

Principal Investigator

Calliditas Therapeutics

Are You a Good Fit for This Trial?

Adults diagnosed with primary IgA nephropathy (kidney disease) who have already completed 9 months of TARPEYO® treatment. They must have consistent proteinuria, be on a stable dose of certain medications for kidney function and diabetes, and have access to their past lab results.

Inclusion Criteria

I have medical records of my condition from the last 3 months before starting TARPEYO®.

I can provide past lab results for kidney function tests.

My recent tests show protein in my urine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TARPEYO® 16 mg QD for 6 months followed by TARPEYO® 8 mg QD for 9 months

15 months

Regular visits for urine tests, blood samples, and physical examinations

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 2-week tapering period with TARPEYO® 4 mg QD

3 months

What Are the Treatments Tested in This Trial?

Interventions

• TARPEYO®

Trial Overview

The trial is testing the benefits and safety of continuing TARPEYO® (delayed-release budesonide capsules) beyond 9 months in adults with IgA nephropathy. It involves urine tests, blood samples, physical exams over approximately 19 months.

How Is the Trial Designed?

Group I: 16 mg QD then 8 mg QD Experimental Treatment 1 Intervention

6-months of TARPEYO® 16 mg QD then 9-month Treatment Period with TARPEYO® 8 mg QD and TARPEYO®4 mg QD for 2 weeks for tapering.

Who Is Running the Clinical Trial?

Calliditas Therapeutics AB

Lead Sponsor

Trials

11

Recruited

1,200+

Worldwide Clinical Trials

Collaborator

Trials

70

Recruited

15,800+

Published Research Related to This Trial

In a study of 132 IgA nephropathy patients with chronic kidney disease, low-dose corticosteroids combined with oral cyclophosphamide significantly reduced the risk of severe kidney decline compared to uncontrolled supportive care, suggesting a more effective treatment option.

The combination therapy also resulted in better renal survival rates and lower proteinuria levels, with no significant increase in hospitalization for infections, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment for IgA nephropathy with stage 3 or 4 chronic kidney disease: low-dose corticosteroids combined with oral cyclophosphamide. Ma, F., Yang, X., Zhou, M., et al.[2021]

In a study involving 82 rats, those that ingested alcohol continuously developed IgA nephropathy, with 60% affected at 6 weeks and 100% by 16 weeks, indicating a strong link between prolonged alcohol consumption and kidney disease.

In contrast, control rats that received a glucose-based diet showed no signs of IgA nephropathy, highlighting the specific impact of alcohol on kidney health in this animal model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time dependency of IgA nephropathy induction in alcohol ingestion. Smith, SM., Tsukamoto, H.[2019]

Eculizumab, an anti-C5 medication, was effective in stabilizing renal function and reducing proteinuria in an adolescent with rapidly progressive IgA nephropathy, despite prior immunosuppressive treatments.

The treatment's benefits were temporary, indicating that early initiation of eculizumab may be crucial in managing progressive IgA nephropathy by targeting complement-mediated inflammation in the kidneys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eculizumab treatment for rescue of renal function in IgA nephropathy. Rosenblad, T., Rebetz, J., Johansson, M., et al.[2022]

Budesonide (Tarpeyo) has been approved to help reduce proteinuria in adults with primary immunoglobulin A nephropathy, indicating its efficacy in managing this kidney condition.

Patients using budesonide should be monitored for potential drug-drug interactions and advised about the increased risk of infections due to its immunosuppressive effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Drug to Reduce Proteinuria in Berger's Disease. Aschenbrenner, DS.[2023]

Corticosteroids and fish oil capsules have shown the most promise as treatment options for patients with IgA nephropathy, based on recent publications.

A multicenter, placebo-controlled study is underway to evaluate the effectiveness of alternate-day prednisone and highly purified fish oil concentrate in children and young adults with moderately severe IgA nephropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in treatment: immunoglobulin A nephropathy. Hogg, RJ., Waldo, B.[2007]

In a study of 60 patients with early-stage IgA nephropathy, treatment with ramipril did not significantly improve outcomes compared to no treatment over a 5-year period, with similar rates of hypertension and proteinuria between groups.

While ramipril was well tolerated overall, the study found no significant benefits in renal function or event-free survival, suggesting that this treatment may not be necessary for patients with minimal proteinuria and normal renal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of early immunoglobulin A nephropathy by angiotensin-converting enzyme inhibitor. Li, PK., Kwan, BC., Chow, KM., et al.[2013]

In a study of 107 patients with IgA nephropathy followed for an average of 6.6 years, the angiotensinogen-M235T genetic polymorphism was linked to the presence of nephrotic syndrome and influenced the deterioration of renal function.

The combination of angiotensinogen-M235T and ACE-I/D polymorphisms showed a synergistic effect on disease progression, suggesting that these genetic markers could be important for predicting outcomes in IgA nephropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of genetic polymorphisms of the renin-angiotensin system on IgA nephropathy. Bantis, C., Ivens, K., Kreusser, W., et al.[2007]

A patient developed crescentic IgA nephropathy after receiving recombinant interleukin-2 (rIL2) and lymphokine-activated killer (LAK) cell therapy for liver cancer, marking the first documented case of this kidney condition linked to these treatments.

The patient's renal function improved partially and stabilized after stopping rIL2 and LAK therapy, along with plasmapheresis and steroid treatment, suggesting that IL2 may play a role in causing kidney injury in IgA nephropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crescentic IgA glomerulonephritis following interleukin-2 therapy for hepatocellular carcinoma of the liver. Chan, TM., Cheng, IK., Wong, KL., et al.[2018]

IgA nephropathy is a common autoimmune kidney disease that can lead to kidney failure, and current treatment options mainly focus on reducing proteinuria through non-specific methods like renin-angiotensin blockade.

There is a significant need for new therapies for IgA nephropathy, as existing treatments, including immunosuppressive agents, are limited and primarily target inflammation rather than the underlying disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating IgA nephropathy: quid novi? Hartono, C., Muthukumar, T.[2021]

IgA nephropathy is a common form of chronic kidney disease that presents significant challenges in understanding its causes and treatment options.

There are promising opportunities for developing new tests and treatments that could help manage and control IgA nephropathy more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IgA nephropathy: challenges and opportunities. Glassock, RJ.[2019]

In a study using Tsukamoto-French alcoholic rats, 67% of the rats developed IgA nephropathy after 6 to 10 weeks of continuous alcohol exposure, while none of the control rats showed this condition, indicating a strong link between alcohol abuse and kidney damage.

The findings revealed renal changes similar to those seen in humans, including mesangial expansion and IgA deposition, suggesting that this rat model effectively mimics the effects of chronic alcohol consumption on kidney health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IgA nephropathy in alcohol abuse. An animal model. Smith, SM., Yu, GS., Tsukamoto, H.[2007]

Citations

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jmcp.org

jmcp.org/doi/10.18553/jmcp.2025.31.5.499

Cost-effectiveness analysis of targeted-release formulation ...

In summary, Tarpeyo was found to be a cost-effective treatment for US adults with primary IgAN based on a pay threshold of $100 000 per QALY ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12041922/

Cost-effectiveness analysis of targeted-release formulation ...

A cost-utility analysis incorporating clinical outcomes from the NefIgArd trial demonstrated the potential cost savings associated with Tarpeyo for the ...

3.

tarpeyohcp.com

tarpeyohcp.com/efficacy

Efficacy of TARPEYO® (budesonide) delayed-release capsules

TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

4.

icer.org

icer.org/wp-content/uploads/2025/07/ICER_IgAN_Public-Comment-Folio_For-Publication_082825.pdf

August 20, 2025

... Tarpeyo®, which is a targeted release form of budesonide, for the treatment of immunoglobulin A nephropathy (IgAN). IgAN is a chronic ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0085253822008365

Results from part A of the multi-center, double-blind, ...

The primary efficacy outcome for part A was the effect of Nefecon on UPCR at 9 months. Secondary efficacy outcomes were eGFR (Chronic Kidney Disease ...

6.

tarpeyo.com

tarpeyo.com/

TARPEYO (budesonide) delayed release capsules site

TARPEYO is a prescription medicine used to reduce the loss of kidney function in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN)

7.

tarpeyohcp.com

tarpeyohcp.com/

TARPEYO® (budesonide) delayed-release capsules - IgA ...

TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

8.

igan.org

igan.org/Tarpeyo_Patient_Brochure.pdf

TAKE CHARGE WITH TARPEYO

TARPEYO is a prescription medicine used to reduce levels of protein in the urine (proteinuria) in adults with IgA Nephropathy who are at high risk of disease ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9846030/

Current knowledge of targeted-release budesonide in ...

In the current trials, the application of TRF-budesonide in the treatment of IgA nephropathy can effectively reduce proteinuria and delay renal function ...

10.

tarpeyo.com

tarpeyo.com/about-tarpeyo

About Tarpeyo

The first FDA-approved medicine that targets a source of IgA Nephropathy. · Slowed kidney function loss · Significantly lowered proteinuria better than placebo + ...