TARPEYO® for Immunoglobulin A Nephropathy (NefXtend Trial)
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Calliditas Therapeutics AB
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice. The main question it aims to answer is:
Is there a treatment benefit of TARPEYO® 16 mg QD extended use?
Participants will
* take part in this study for about 19 months
* Have urine tests done
* Have blood samples taken
* Have physical examinations done
How is the drug TARPEYO® unique in treating IgA nephropathy?
TARPEYO® (budesonide) is unique because it specifically targets and reduces proteinuria (excess protein in urine) in adults with IgA nephropathy, also known as Berger's disease. Unlike other treatments, it works by suppressing the immune system, which can increase the risk of infections, so patients need to be cautious about exposure to infections.
678911Is TARPEYO® (budesonide) safe for humans?
TARPEYO® (budesonide) can suppress the immune system, which may increase the risk of infections. Patients should be cautious and avoid contact with people who have infections.
123511What data supports the effectiveness of the drug TARPEYO® for treating Immunoglobulin A Nephropathy?
Budesonide (Tarpeyo) has been approved to reduce proteinuria (excess protein in urine) in adults with primary immunoglobulin A nephropathy, indicating its effectiveness in managing this condition.
4781011Will 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.
Eligibility Criteria
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 been diagnosed with IgA nephropathy through a kidney biopsy.
I have completed 9 months of TARPEYO® treatment.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: 16 mg QD then 8 mg QDExperimental Treatment1 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Dallas Renal GroupDallas, TX
Arizona Kidney Disease & Hypertension Centers (AKDHC)Glendale, AZ
Florida Kidney PhysiciansBoca Raton, FL
Cobb Nephrology Hypertension Associates, PCAustell, GA
More Trial Locations
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Who is running the clinical trial?
Calliditas Therapeutics ABLead Sponsor
Worldwide Clinical TrialsCollaborator
References
Time dependency of IgA nephropathy induction in alcohol ingestion. [2019]We investigated the influence of the alcohol ingestion period on the incidence of IgA nephropathy in an animal model. A group of 41 rats received a continuous infusion of liquid diet and alcohol: "alcoholics." A further group of 41 control rats received an isocaloric diet in which the alcohol was replaced by glucose. IgA nephropathy was diagnosed by the presence of intense IgA deposition in the mesangium. At 6 weeks, 60% of the alcoholic rats had IgA nephropathy. The incidence increased until 100% of the alcoholic rats presented the renal disease at 16 weeks. IgA nephropathy was not found in any of the control animals. We conclude that, in this animal model, the incidence of IgA nephropathy is dependent on the time frame of the alcohol ingestion.
Crescentic IgA glomerulonephritis following interleukin-2 therapy for hepatocellular carcinoma of the liver. [2018]A patient who developed crescentic IgA nephropathy following treatment with recombinant interleukin-2 (rIL2) and lymphokine-activated killer (LAK) cell therapy for hepatocellular carcinoma was reported. Cessation of rIL2 and LAK cell treatment plus plasmapheresis and steroid therapy was successful in achieving partial improvement and stabilization of renal function. This is the first case report of biopsy-documented glomerulonephritis developing after IL2 and LAK cell therapy. This provides indirect in vivo evidence for the role of IL2 in mediating glomerular injury in IgA nephropathy.
IgA nephropathy in alcohol abuse. An animal model. [2007]In search of an animal model for alcohol abuse related IgA nephropathy, we investigated the Tsukamoto-French alcoholic rat. Continuous intoxication was induced by gastric infusion of a liquid diet with up to 47% ethanol in Wistar rats designated "alcoholic". Control animals received the same calorie count in the form of glucose. Animals were sacrificed after 6 or 10 weeks. IgA nephropathy was observed in 67% (10 of 15) of alcoholic rats and in none of 14 controls (p less than 0.0002). Alcohol abuse related renal changes, similar to those described in humans were present. These included mild mesangial expansion and intense IgA deposition. Foot process effacement was observed in alcoholic animals; severe proteinuria was found in half the animals with IgA nephropathy. This is the first report of chronic ethanol ingestion induced mesangial IgA nephropathy in an animal model.
Advances in treatment: immunoglobulin A nephropathy. [2007]In this article, we consider a number of treatment options for patients with IgA nephropathy. Major emphasis will be placed on the use of corticosteroids and fish oil capsules because these have shown the most promise in recent publications. We also consider the specific management of two patients with severe manifestations of this disease and describe their responses. Finally, we consider future avenues of research into the treatment of IgA nephropathy. This includes a brief description of a three-arm multicenter, placebo-controlled study evaluating alternate-day prednisone and highly purified fish oil concentrate (Omacor) in children and young adults with moderately severe forms of IgA nephropathy.
Influence of genetic polymorphisms of the renin-angiotensin system on IgA nephropathy. [2007]We evaluated the impact of the three major genetic polymorphisms of the renin-angiotensin system [angiotensinogen (AGT) gene M235T, angiotensin-converting enzyme (ACE) gene-I/D and angiotensin II-type 1 receptor (AT1R) gene A1166C polymorphisms] as risk factors in IgA nephropathy.
IgA nephropathy: challenges and opportunities. [2019]Immunoglobulin A (IgA) nephropathy poses many challenges to investigators and physicians in its etiology, pathogenesis, prevention, and treatment. But at the same time, opportunities abound for new tests and treatments that may eventually lead to control of this common form of chronic kidney disease.
Treatment of early immunoglobulin A nephropathy by angiotensin-converting enzyme inhibitor. [2013]The treatment of immunoglobulin A (IgA) nephropathy with normal renal function and minimal proteinuria is unknown.
Treating IgA nephropathy: quid novi? [2021]IgA nephropathy is a common autoimmune renal disease resulting in kidney failure for patients with significant proteinuria. The therapeutic options are limited including non-specific treatment to reduce proteinuria accomplished by renin-angiotensin blockade. Strategies to control intrarenal inflammation include the administration of fish oil and for severe disease the use of immunosuppressive agents such as cyclophosphamide, glucocorticosteroids, and mycophenolate mofetil. In light of the limited option, there is an unmet need for novel therapeutic intervention in patients with progressive disease. Herein, we review the evidence for existing treatment choices and explore new immunopharmacologic agents being investigated for IgA nephropathy.
Eculizumab treatment for rescue of renal function in IgA nephropathy. [2022]Immunoglobulin A (IgA) nephropathy is a chronic glomerulonephritis with excessive glomerular deposition of IgA1, C3 and C5b-9, which may lead to renal failure.
Treatment for IgA nephropathy with stage 3 or 4 chronic kidney disease: low-dose corticosteroids combined with oral cyclophosphamide. [2021]The use of immunosuppressive therapy for IgA nephropathy patients with renal insufficiency and severe proteinuria is controversial.
First Drug to Reduce Proteinuria in Berger's Disease. [2023]Budesonide (Tarpeyo) has received accelerated approval to reduce proteinuria in adults with primary immunoglobulin A nephropathy, also known as Berger's disease.Nurses should assess if any coprescribed drugs could induce a drug-drug interaction via the cytochrome P-450 isoenzyme system. Because budesonide causes immunosuppression, patients are at high risk for developing infections and should be told to avoid anyone who is known to have an infection.