Diabetic NephropathiesNCT05418465
Huangqi Guizhi Wuwu Decoction in CKD Stage 2-4 Diabetic Nephropathy
A study testing Huangqi Guizhi Wuwu decoction and Dapagliflozin in people with Diabetic Nephropathies, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial summary
This is a prospective, open, multicenter clinical trial.The objective of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction in patients with CKD stage 2-4 diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Huangqi Guizhi Wuwu decoction and Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients diagnosed as diabetic nephropathy
- TCM syndrome differentiation is Qi deficiency and blood stasis type
- Male or female, 18≤age≤75 4.25mL/（min.1.73m2）≤ eGFR<90mL/（min.1.73m2） 5.24-hour urine protein ration ≤3.5g/24h
- 6.The participants must be capable of understanding and comply with the protocol and sign a written informed consent document
Who cannot join
- Exposure to immunosuppressors, glucocorticoid，without a one weeks washout period
- Urinary tract infection (leukocytes in urinary sediment > 5 / HP)
- Serum potassium > 5.5 mmol/L
- Serum albumin < 30g/L
- Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
- Having comorbidities that affect the progression of diabetic nephropathy (including but not limited to Malignant tumors, Systemic autoimmune diseases, Liver cirrhosis)
- Participating in another clinical trial
- Investigators do not think it suitable for a participant to join this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Dalian medical university
Dalian, Liaoning, 116011
Dapeng Wang, MD, +86-18098875653, bobowdp@163.com
About this study
Official title: A Prospective, Open, Multicenter, Clinical Study of Huangqi Guizhi Wuwu Decoction in Treating Diabetic Nephropathy (Stage CKD2-4)
This is a prospective, open, multicenter clinical trial.The objective of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction in patients with CKD stage 2-4 diabetic nephropathy.
Read the detailed description
The incidence rate of chronic kidney disease is 10.8% in China. The incidence rate of diabetic nephropathy has increased year by year, and now it has become the first cause of uremia. Therefore, the treatment of diabetic nephropathy can delay the progression of renal function and is of great value and significance in reducing uremia. Huangqi Guizhi Wuwu decoction is a traditional Chinese medicine decoction. Previous studies have shown that it is effective in the treatment of diabetic nephropathy. In this study, there were 2 hospitals participating in. We planned to enroll 100 participants, who will be divided into the Huangqi Guizhi Wuwu decoction group (experimental group) and the Dapagliflozin group (control group). All participants will take medication for 12 weeks, and investigators will follow up participates at weeks 0, 2,4, 6, 8,12.
- Conditions
- Diabetic Nephropathies
- Being tested
- Huangqi Guizhi Wuwu decoction, Dapagliflozin
- Keywords
- Diabetic nephropathy,Huangqi Guizhi Wuwu Decoction (CKD2-4)
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huangqi Guizhi Wuwu decoctionDrug
Huangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration.
DapagliflozinDrug
Dapagliflozin, 10mg at a time, once a day. Oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Huangqi Guizhi Wuwu decoction group | Experimental | Huangqi Guizhi Wuwu decoction Receives: Drug: Huangqi Guizhi Wuwu decoction |
| Dapagliflozin group | Active comparator | Dapagliflozin Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Change in 24-hour urine protein ration from baseline.
24-hour urinary protein quantification is being assessed once every 4 weeks for a total of 4 times during the whole study.
Measured: Start of treatment until the end of the treatment for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start26 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Fang, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418465
- Sponsor's protocol ID
- PJ-KS-KY-2021-228(X2)
- Status last verified
- Jun 2022
- First submitted
- 10 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Multicenter, Clinical Study of Huangqi Guizhi Wuwu Decoction in Treating Diabetic Nephropathy (Stage CKD2-4)
- ClinicalTrials.gov ID
- NCT05418465
- Acronym / sponsor ID
- PJ-KS-KY-2021-228(X2)
- Conditions
- Diabetic Nephropathies
- Keywords
- Diabetic nephropathy,Huangqi Guizhi Wuwu Decoction (CKD2-4)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Jun 2022 (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.
This is a prospective, open, multicenter clinical trial.The objective of this study is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu Decoction in patients with CKD stage 2-4 diabetic nephropathy.
Detailed description
The incidence rate of chronic kidney disease is 10.8% in China. The incidence rate of diabetic nephropathy has increased year by year, and now it has become the first cause of uremia. Therefore, the treatment of diabetic nephropathy can delay the progression of renal function and is of great value and significance in reducing uremia. Huangqi Guizhi Wuwu decoction is a traditional Chinese medicine decoction. Previous studies have shown that it is effective in the treatment of diabetic nephropathy. In this study, there were 2 hospitals participating in. We planned to enroll 100 participants, who will be divided into the Huangqi Guizhi Wuwu decoction group (experimental group) and the Dapagliflozin group (control group). All participants will take medication for 12 weeks, and investigators will follow up participates at weeks 0, 2,4, 6, 8,12.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huangqi Guizhi Wuwu decoction group | Experimental | Drug: Huangqi Guizhi Wuwu decoctionHuangqi Guizhi Wuwu decoction |
| Dapagliflozin group | Active comparator | Drug: DapagliflozinDapagliflozin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed as diabetic nephropathy
- TCM syndrome differentiation is Qi deficiency and blood stasis type
- Male or female, 18≤age≤75 4.25mL/（min.1.73m2）≤ eGFR<90mL/（min.1.73m2） 5.24-hour urine protein ration ≤3.5g/24h
- 6.The participants must be capable of understanding and comply with the protocol and sign a written informed consent document
Key exclusion criteria (8 listed)
- Exposure to immunosuppressors, glucocorticoid，without a one weeks washout period
- Urinary tract infection (leukocytes in urinary sediment > 5 / HP)
- Serum potassium > 5.5 mmol/L
- Serum albumin < 30g/L
- Pregnant or lactating women, and participants (including males) who were unable or unwilling to take adequate contraception during the study period
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 |
|---|---|---|
| Huangqi Guizhi Wuwu decoctionHuangqi Guizhi Wuwu decoction, 100ml at a time, 2 times a day. Oral administration. | Drug | Huangqi Guizhi Wuwu decoction group |
| DapagliflozinDapagliflozin, 10mg at a time, once a day. Oral administration. | Drug | Dapagliflozin group |
Primary outcome
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline
Time frame: 12 weeks
Events based on eGFR measure compared to baseline calculated using the CKD-EPI formula.
1 secondary outcome
Change in 24-hour urine protein ration from baseline.
Time frame: Start of treatment until the end of the treatment for 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The First Affiliated Hospital of Dalian medical university
Dalian, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Huangqi Guizhi Wuwu decoction and Dapagliflozin in people with Diabetic Nephropathies, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2022.