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Huaiqihuang Granule in the Treatment of Primary Glomerulonephritis of Stage CKD3

ConditionRenal Insufficiency, Chronic
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First Affiliated Hospital of Dalian Medical University

About this trial

This is a multicentre prospective, randomized, double-blind and imitation, positive-drug parallel controlled clinical trail. The objective of this study is to evaluate the efficacy and safety of Huaiqihuang Granule in patients with CKD stage 3 primary glomerulonephritis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed as primary glomerulonephritis by renal biopsy

Male or female, 18≤age≤65

Blood pressure can be effectively controlled at or below 140/90mmHg

30mL/（min.1.73m2）≤ eGFR<60mL/（min.1.73m2）

Disqualifiers

Diagnosed as secondary glomerulonephritis

Exposure to corticosteroids, immunosuppressors, tripterygium glycosides, ARBs or ACEIs, without a two weeks washout period

Blood pressure < 90/60 mmHg

Serum potassium > 5.5 mmol/L

Trial design

Design model

Parallel

Treatments tested in this trial

  • Huaiqihuang granules

    Drug

    Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.

  • Valsartan capsule

    Drug

    Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.

Treatment groups

466 Participants
are divided into 2 treatment groups
Group A: Huaiqihuang groupExperimental treatment 1 intervention
Group B: Valsartan GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline

Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.

Time frame
48 weeks

Secondary outcomes

1

Change in serum creatinine levels from baseline

Serum creatinine is being assessed once every 8 weeks for a total of 6 times during the whole study

Time frame
Start of treatment until the end of the treatment for 48 weeks
2

Change in 24-hour urine protein ration from baseline.

Urinary protein is being assessed once every 8 weeks for a total of 6 times during the whole study

Time frame
Start of treatment until the end of the treatment for 48 weeks
3

Changes in urine erythrocyte levels from baseline

Urine erythrocyte is being assessed once every 8 weeks for a total of 6 times during the whole study

Time frame
Start of treatment until the end of the treatment for 48 weeks

Other outcomes

1

Composite endpoint incidence

The incidence of endpoint events：① eGFR decreased by 15% from baseline and was reviewed within 2 weeks, if no improvement was found or if the eGFR continued to decrease by 15% below baseline；② Serum creatinine doubles or enters maintenance of renal replacement therapy or death

Time frame
Start of treatment until the end of the treatment for 48 weeks
2

Incidence of adverse events

The proportion of patients with adverse events to the total population.

Time frame
Start of treatment until the end of the treatment for 48 weeks
3

Incidence of adverse reactions

The proportion of patients with adverse reactions to the total population

Time frame
Start of treatment until the end of the treatment for 48 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Dalian Medical University

Lead sponsor

Huazhong University of Science and Technology

Collaborator

LinkDoc Technology (Beijing) Co. Ltd.

Collaborator

Source ClinicalTrials.gov
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