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New drug combo shows promise for kidney disease in small trial

NCT ID NCT05834738

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study tested whether adding the drug atrasentan to standard care (including SGLT2 inhibitors) can reduce protein in the urine of people with IgA nephropathy, a kidney disease. 54 adults with biopsy-confirmed IgA nephropathy participated. The main goal was to see if atrasentan lowers proteinuria more than placebo over 12 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

54 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Legal adults (per local and country specifications) ≥ 18 years of age at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures. * Biopsy-proven IgA nephropathy. * Receiving a maximally tolerated and stable dose of a RASi for at least 12 weeks prior to screening. Investigator discretion should be used in determining maximally tolerated and optimized dose. * eGFR of at least 30 mL/min/1.73 m\^2 at screening based on the 2021 CKD-EPI equation. * Willing to agree to highly effective forms of contraception, as specified in the protocol, throughout the study and for up to 1 month afterward. In WOCBP, use of hormonal contraceptive agents must have been started at least 1 month prior to baseline. * Willing and able to provide informed consent and comply with all study requirements. * Inclusion Criteria for SGLT2i stable subjects * Receiving a stable dose of an SGLT2i for at least 8 weeks prior to screening * Must have a 24-hour urine protein of \>0.5 grams/day. * Inclusion Criteria for Run-In Subjects * Must have a 24-hour total urine protein of \>0.85 grams/day at screening * Willing to participate in an 8-week run-in period with an SGLT2i (per Investigator choice) * Additional Inclusion Criteria for Run-in Subjects at the end of Run-In * Must have completed the 8-week run-in period on a stable and well tolerated dose of an SGLT2i * Must have a 24-hour total urine protein of \>0.5 grams/day confirmed at the Run-in Week 8 visit. * Must have an eGFR of ≥ 30 mL/min/1.73 m\^2 based on the CKD-EPI equation at their Run-in Week 8 visit. Exclusion Criteria: * Current diagnosis with another chronic kidney disease, including diabetic kidney disease. * History of kidney transplantation or other organ transplantation. * Use of systemic immunosuppressant medications, such as steroids, for more than 2 weeks in the past 3 months. * Blood pressure above 150 mmHg systolic or 95 mmHg diastolic as evaluated by the Investigator. * Known history of heart failure or prior hospital admissions for conditions relating to fluid overload that in the opinion of the Principal Investigator or Sponsor might confound the results of the study or pose additional risk to the participant by their participation in the study. * Clinically significant history of liver disease as assessed by the Investigator. * Hemoglobin below 9 g/dL as measured by the Investigator or prior history of blood transfusion for anemia within the past 3 months. * Malignancy within the past 5 years. Exceptions to this criteria include nonmelanoma skin cancer and curatively treated cervical carcinoma in situ. * For women, pregnancy, breast feeding, or intent to become pregnant during the study. and at least 1 month afterward. * For men, intent to father a child or donate sperm during the study. * Have received any investigational agent or approved treatment for IgAN (other than a RAS inhibitor) including SGLT2i (except for subjects in the SGLT2i stable stratum) within 1 month (or 5 half-lives of the agent, whichever is longer) prior to Screening. If the investigational agent is a cytotoxic or immunosuppressive agent then this washout period is 6 months.

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Conditions

The condition(s) this trial relates to.

chronic renal failure syndrome glomerulonephritis IgA glomerulonephritis kidney disorder urinary system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IgA nephropathy Immunoglobulin A nephropathy

Contacts and locations

Locations

  • Chung-Ang University College

    Seoul, Seoul, 06973, South Korea

  • Dong-A University Medical Center (Dong-A University Hospital)

    Busan, Busan, 49201, South Korea

  • Fides Clinical Research

    Atlanta, Georgia, 30342, United States

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, 14068, South Korea

  • Hopsital Sultanah Aminah Johor Bharu (HSAJB) - Bangunan Bakawali Heodialysis Centre

    Johor Bahru, Johor Darul Takzim, 80100, Malaysia

  • Hospital 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Clinico Universitario

    Valencia, 46010, Spain

  • Hospital Raja Permaisuri Bainun (HRPB)

    Ipoh, Perak, 30450, Malaysia

  • Hospital Ribera Polusa

    Lugo, 27004, Spain

  • Hospital Torrecardenas

    Almería, 04009, Spain

  • Hospital Universitario De Getafe (HUG)

    Madrid, 28009, Spain

  • Hospital Virgen Macarena

    Seville, 41009, Spain

  • Hospital das Clinicas da Faculdade de Medicina da USP

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hospital del Vall d´Hebron

    Barcelona, 08035, Spain

  • Monash Health- Monash Medical Centre

    Melbourne, Victoria, 3168, Australia

  • NANI Research

    Oak Brook, Illinois, 60523, United States

  • NUPEC Cardio

    Belo Horizonte, Minas Gerais, 30220-140, Brazil

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031, Australia

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

  • Soon Chun Hyang Central Medical Center (SCHMC) - Soon Chun Hyang University Hospital

    Cheonan, Chungnam-Do, 31151, South Korea

  • Sunshine Hospital

    St Albans, Victoria, 3021, Australia

  • The St. George Hospital

    Kogarah, New South Wales, 2217, Australia

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Universidade Federal de Sao Paulo

    São Paulo, São Paulo, 04038-002, Brazil

  • Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM))

    Cheras, Kuala Lumpur, 56000, Malaysia

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

  • University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Nephrology Clinic

    Birmingham, Alabama, 35233, United States

  • University of North Carolina at Chapel Hill - Nephrology and Hypertension

    Chapel Hill, North Carolina, 27599, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.