IgA Nephropathy (IgAN)NCT07360002

The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy

A study testing Shenqi Yishen Granules in people with IgA Nephropathy (IgAN), run by Keda Lu.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

The goal of this clinical trial is to learn if Shenqi Yishen Granules works to treat IgA Nephropathy in adults. It will also learn about the safety of Shenqi Yishen Granules. The main questions it aims to answer are: Does Shenqi Yishen Granules lower 24-hour urinary protein quantification of participants? What medical… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: IgA Nephropathy (IgAN)
What is being tested?: Shenqi Yishen Granules
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 102 participants
Where: No sites listed yet
Study dates: Jan 2026to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meets the diagnostic criteria for IgA nephropathy and CKD stages 1-2, 24h-HPro > 0.3g;
Meets the diagnostic criteria for "qi and yin deficiency syndrome" according to Traditional Chinese Medicine;
Age between 18 and 75 years, gender;
Infection, acidosis, electrolyte imbalance, hypertension, etc., are well controlled;
No failure of other organ functions;
Have good compliance, have not participated in other clinical trials in the past six months; are informed and voluntarily willing to participate in the clinical study.

Who cannot join

(1) Immediate dialysis treatment is required; currently undergoing treatment with hormones, non-steroidal anti-inflammatory drugs, or immunosuppressive agents; (2) Patients with acute infectious diseases or those under surgical or traumatic stress; (3) Patients with chronic infectious diseases such as active chronic hepatitis B,, decompensated cirrhosis, or active tuberculosis; (4) Patients with severe organ dysfunction affecting survival, such as malignant tumors or HIV infection; (5) Patients with severe primary diseases of the cardiovascular, hematological, neurological, digestive, or respiratory systems, or those with a significant tendency to bleed; (6) Patients with life-threatening conditions such as hyperkalemia or heart failure; (7) Patients with a GFR fluctuation of ≥30% within the past 3 months; (8) Patients with severe allergies to certain known drugs in this study or unable to tolerate them; (9) Patients who are pregnant or breastfeeding; (10) Patients with a history of drug abuse or who have used immunosuppressive agents or glucocorticoids in the past 3 months; (11) Patients with major bleeding or blood transfusion history in the past 3 months, or those with severe clinical infections or signs of acidosis; (12) Patients currently participating in other clinical trials or undergoing other Chinese herbal treatments that may affect efficacy assessment; (13) Patients planning or having undergone kidney transplantation, or those with acute or chronic kidney failure requiring immediate replacement therapy; (14) Patients with post-renal factors, such as obstruction (including stones, uric acid crystals, or tumors) causing acute kidney injury; (15) Patients with a history of mental illness or communication/cognitive impairments leading to poor compliance and inability to cooperate; (16) Non-Asian individuals.

About this study

Does Shenqi Yishen Granules lower 24-hour urinary protein quantification of participants? What medical problems do participants have when taking Shenqi Yishen Granules? Researchers will compare Shenqi Yishen Granules to a placebo (a look-alike substance that contains no drug) to see if Shenqi Yishen Granules works to treat IgA Nephropathy.

Conditions: IgA Nephropathy (IgAN)
Being tested: Shenqi Yishen Granules, Placebo
Medical subject headings: Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Shenqi Yishen GranulesDrug
Also called Irbesartan
A traditional Chinese medicine compound for the treatment of IgA nephropathy
PlaceboDrug
Also called Irbesartan
a look-alike substance that contains no drug

Study groups in NCT07360002
Study group	Role	What they receive
Treatment group	Experimental	Shenqi Yishen Granules + Irbesartan Receives: Drug: Shenqi Yishen Granules
Control Group	Placebo comparator	Chinese herbal placebo + Irbesartan Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

24-hour urinary protein quantification
24-hour urinary protein quantification
Measured: 0 weeks, 4 weeks, 8 weeks, 12 weeks
Protein-to-creatinine rati
Concentration of Protein-to-creatinine rati
Measured: 0 weeks, 4 weeks, 8 weeks, 12 weeks

Secondary outcomes (4)

Red blood cells in urine
Red blood cells in urine
Measured: 0 weeks, 4 weeks, 8 weeks, 12 weeks
Glomerular filtration rate
Glomerular filtration rate
Measured: 0 weeks, 4 weeks, 8 weeks, 12 weeks
The number of infections in the respiratory, gastrointestinal, or urinary tract
The number of infections in the respiratory, gastrointestinal, or urinary tract
Measured: 0 weeks, 4 weeks, 8 weeks, 12 weeks
TCM syndrome score
Assess the patient's clinical symptoms based on the rating scale; the higher the score, the more severe the symptoms.
Measured: 0 weeks, 4 weeks, 8 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2026Dec 2026

First posted22 Jan 2026
Study startJan 2026 (estimated)
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 102 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07360002
Sponsor's protocol ID: ZSLL-KY-2025-129-01
Status last verified: Jan 2026
First submitted: 5 Jan 2026
Last updated: 22 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data involves the personal privacy of participants and should not be made public or shared.

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

All IgA Nephropathy (IgAN) trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy
ClinicalTrials.gov ID: NCT07360002
Acronym / sponsor ID: ZSLL-KY-2025-129-01
Conditions: IgA Nephropathy (IgAN)
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 102 participants (estimated)
Lead sponsor: Keda LuUniversity, hospital or other
Collaborators: The First Affiliated Hospital of Zhejiang Chinese Medical University, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Red Cross Hospital, Hangzhou, China, Hangzhou Hospital of Traditional Chinese Medicine, Zhenhai District Traditional Chinese Medicine Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Shao Yifu Hospital of Zhejiang Medical University, First Affiliated Hospital of Zhejiang University, Yuyao City Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Affiliated Hospital of Jiaxing University, Hangzhou Xiaoshan First People's Hospital, Shanghai 6th People's Hospital
Study start: Jan 2026 (estimated)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 22 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment group	Experimental	Drug: Shenqi Yishen GranulesShenqi Yishen Granules + Irbesartan
Control Group	Placebo comparator	Drug: PlaceboChinese herbal placebo + Irbesartan

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Meets the diagnostic criteria for IgA nephropathy and CKD stages 1-2, 24h-HPro > 0.3g;
Meets the diagnostic criteria for "qi and yin deficiency syndrome" according to Traditional Chinese Medicine;
Age between 18 and 75 years, gender;
Infection, acidosis, electrolyte imbalance, hypertension, etc., are well controlled;
No failure of other organ functions;

Key exclusion criteria (1 listed)

(1) Immediate dialysis treatment is required; currently undergoing treatment with hormones, non-steroidal anti-inflammatory drugs, or immunosuppressive agents; (2) Patients with acute infectious diseases or those under surgical or traumatic stress; (3) Patients with chronic infectious diseases such as active chronic hepatitis B,, decompensated cirrhosis, or active tuberculosis; (4) Patients with severe organ dysfunction affecting survival, such as malignant tumors or HIV infection; (5) Patients with severe primary diseases of the cardiovascular, hematological, neurological, digestive, or respiratory systems, or those with a significant tendency to bleed; (6) Patients with life-threatening conditions such as hyperkalemia or heart failure; (7) Patients with a GFR fluctuation of ≥30% within the past 3 months; (8) Patients with severe allergies to certain known drugs in this study or unable to tolerate them; (9) Patients who are pregnant or breastfeeding; (10) Patients with a history of drug abuse or who have used immunosuppressive agents or glucocorticoids in the past 3 months; (11) Patients with major bleeding or blood transfusion history in the past 3 months, or those with severe clinical infections or signs of acidosis; (12) Patients currently participating in other clinical trials or undergoing other Chinese herbal treatments that may affect efficacy assessment; (13) Patients planning or having undergone kidney transplantation, or those with acute or chronic kidney failure requiring immediate replacement therapy; (14) Patients with post-renal factors, such as obstruction (including stones, uric acid crystals, or tumors) causing acute kidney injury; (15) Patients with a history of mental illness or communication/cognitive impairments leading to poor compliance and inability to cooperate; (16) Non-Asian individuals.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Shenqi Yishen GranulesAlso: IrbesartanA traditional Chinese medicine compound for the treatment of IgA nephropathy	Drug	Treatment group
PlaceboAlso: Irbesartana look-alike substance that contains no drug	Drug	Control Group

Primary outcome

24-hour urinary protein quantification
Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks
24-hour urinary protein quantification
Protein-to-creatinine rati
Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks
Concentration of Protein-to-creatinine rati

4 secondary outcomes

Red blood cells in urine
Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks
Glomerular filtration rate
Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks
The number of infections in the respiratory, gastrointestinal, or urinary tract
Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks
TCM syndrome score
Time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Individual participant dataSharing planned: No. Individual participant data involves the personal privacy of participants and should not be made public or shared.

Related trials for IgA Nephropathy (IgAN)

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Shenqi Yishen Granules in people with IgA Nephropathy (IgAN), run by Keda Lu.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour urinary protein quantification (time frame: 0 weeks, 4 weeks, 8 weeks, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07360002.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.