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Blood test may help doctors Fine-Tune kidney disease therapy
NCT ID NCT07822100
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether regularly checking a marker called Gd-IgA1 can help doctors adjust treatment for IgA nephropathy, a kidney disease. Adults with biopsy-confirmed IgA nephropathy or IgA vasculitis-associated nephritis receive Nefecon or telitacicept. Half have Gd-IgA1 checked five times during the study to guide medication changes, while the other half receive standard care. The study measures changes in protein in the urine and kidney function to see if the monitoring approach works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gd-IgA1 monitoring to guide medication adjustment in people treated with Nefecon or telitacicept
- What this could lead to
- If it works, doctors could use regular Gd-IgA1 checks to tailor IgA nephropathy treatment and better protect kidney function.
- What could go wrong
- This is an open-label study, so expectations may influence results. Monitoring adds tests and visits, and it may not improve outcomes over standard care.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 374 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Male or female, between 18 and 75 years age; * Biopsy confirmed diagnosis of primary IgA nephropathy or IgA Vasculitis-Associated Nephritis; * Persistent proteinuria, defined as: two separate measurements (with an interval of ≥ 4 weeks) of 24-hour urinary protein excretion (24hUTP) ≥ 0.5 g/day, or urine protein-to-creatinine ratio (UPCR) ≥ 0.44 g/g; * Estimated glomerular filtration rate (eGFR) (CKD-EPI) ≥ 30 ml/min per 1.73m\^2; * Have received the angiotensin converting enzyme Inhibitors(ACEI) / angiotensin receptor blocker(ARB) standard treatment for 4 weeks prior to randomization; * Intending to receive or having received Nefecon or telitacicept treatment for ≤ 2 weeks at the time of screening. Exclusion Criteria: * Secondary IgA nephropathy (excluding IgA vasculitis) caused by ankylosing spondylitis, systemic lupus erythematosus, viral hepatitis, liver cirrhosis, etc.; * With a known history or clinical evidence of concurrent renal diseases other than IgA nephropathy; * Treating with systemic corticosteroids or immunosuppressants including cyclophosphamide, azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine, rituximab, etc. within 3 months prior to randomizing; * Have initiated or had a dose adjustment of leflunomide, tripterygium wilfordii or hydroxychloroquine within 3 months prior to randomizing; * Active tuberculosis or latent carrier without treatment; * Herpes zoster infected patients or patients with positive HIV antibody, positive HCV antibody or HBV infection (According to the HBV screening test, a) the HBsAg-positive; b) HBsAg-negative and HBcAb-positive, the HBV-DNA should be tested to determine the situation: the HBV-DNA positive subjects should be excluded, while the HBV-DNA negative subjects can participated in.) * Suffering from following gastrointestinal diseases: gastric ulcer bleeding within the past 6 months, active inflammatory bowel disease, a history of major gastrointestinal surgery (e.g., gastrectomy, gastroenterostomy, or bowel resection), or pancreatic injury/pancreatitis within the past 6 months; * A confirmed history of osteoporosis or osteonecrosis of the femoral head; * Type 1 or type 2 diabetes with poor glycemic control (HbA1c \> 8%); * Body mass index (BMI) \< 18.5 kg/m².; * Systolic blood pressure (SBP) \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg; * Decreased lymphocyte count (absolute value \< 1.1 × 10⁹/L) or decreased immunoglobulin G (IgG \< 6 g/L). * Hepatic dysfunction, meeting any of the following: a) Child-Pugh Class C liver dysfunction; b) ALT or AST \> 2 × upper limit of normal (ULN), or total bilirubin \> 2 × ULN at screening; c) history of hepatic encephalopathy, esophageal varices, or portosystemic shunt surgery; * Evidence of urinary tract obstruction or dysuria. * A history of solid organ transplantation, hematopoietic stem cell/cell/bone marrow transplantation, or kidney transplantation. * Pregnancy, lactation, female participants with childbearing plans during the trial or within 6 months of its completion, and male participants planning to conceive or donate sperm during the trial or within 3 months of its completion; * With a history of malignant tumors within the past 5 years (excluding cutaneous squamous cell carcinoma or basal cell carcinoma); * Allergy to human-derived biologics; * Nephrotoxic drugs is unavoidable during the study period; * Not suitable for the study judged by investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, 100010, China
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- Can a single injection drug calm the immune attack on kidneys?
- Can engineered immune cells tame autoimmune kidney disease?
- Can an Anti-Inflammatory diet protect the kidneys? a trial puts the autoimmune protocol to the test
- Atacicept's Long-Term promise for kidney disease