AzTrials
AzTrials

Acute Kidney InjuryNCT06071533

Effectiveness and Safety of Danshen Injection for Acute Kidney Injury in Primary Nephrotic Syndrome

An observational study of Acute Kidney Injury and Nephrotic Syndrome, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this real-world observational study is to evaluate the effectiveness and safety of the Chinese herbal-derived therapeutic Danshen injection following immunosuppressive therapy and prophylactic anticoagulation with low molecular heparin for acute kidney injury in primary nephrotic syndrome. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Dandshen
Type of treatment
Injection or infusion
How many people
441 participants
Where
1 siteChina
Study dates
1 Jan 2012to 3 Oct 2023
Phase
Observational
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will be conducted using Hospital Information System of the First Affiliated Hospital of Wenzhou Medical University which has longitudinal health information on over 6 million predominantly privately insured individuals and includes over 50 million followup records. 3873 patients with nephrotic syndrome will be reviewed retrospectively. Patients' information includes socio-demographic characteristics, administrative claims (diagnosis and procedure codes), medical histories, laboratory test results and pharmacy claims.

Who may be able to join

  • age >=20yr;
  • Patients must have at least one "Evaluation and Management"visit with a diagnosis of PNS 6 months before index date;
  • Patients must have AKI at the index date.

Who cannot join

  • Secondary necrotic syndrome, which is define as necrotic syndrome caused by diabetic nephropathy, lupus nephritis, castleman syndrome, cryoglobulinemia, lymphoma, systemic vasculitis, hepatitis C associated nephritis, hepatitis B associated nephritis, monoclonal immunoglobulinemia, amyloidosis, Sjogren's disease, myeloma, macroglobulinemia and Henoch-Schonlein purpura nephritis；
  • Cancer patients；
  • Liver cirrhosis；
  • Transplant patients;
  • Guillain-Barre syndrome；
  • Maintain Remission in PNS；
Show all 13Show fewer
  • Chronic renal failure；
  • PNS without AKI;
  • PNS with autosomal dominant polycystic kidney disease;
  • AKI caused by bleeding, haemolytic uraemic syndrome, malignant hypertension，IgG4 related tubulointerstitial nephritis, infection, acute coronary syndrome or heart failure, obstructive nephropathy and nephrotoxic drug ;
  • PNS accompanied with pulmonary embolism, acute cerebrovascular accident,Pregnancy;
  • Acute rapid progressive or Crescentic Glomerulonephritis;
  • Patients without valid data .

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

Other trials in China

About this study

The goal of this real-world observational study is to evaluate the effectiveness and safety of the Chinese herbal-derived therapeutic Danshen injection following immunosuppressive therapy and prophylactic anticoagulation with low molecular heparin for acute kidney injury in primary nephrotic syndrome. The main questions to answer are:

Whether or not Danshen injection is beneficial for acute kidney injury patients in primary nephrotic syndrome patients.

Read more

Whether or not Danshen injection will increase the bleeding risk in primary nephrotic syndrome patients receiving low molecular heparin.

Participants' information will be retrieved from hospital files stored in medical records and the electronic patient data registry. Participants received Danshen injection will be compared with control group to evaluate the recovery of renal function and side effects.

Read the detailed description

Background and objectives： Acute kidney injury (AKI) is a common complication of primary nephrotic syndrome (PNS), affecting approximately 23.7% to 34% of PNS patients. No randomized clinical trials and clinical drug intervention studies focus on renal function recovery of AKI in PNS patients. The aim of this study is to assess the clinical effectiveness and safety of a common traditional Chinese herbal medicine (Danshen) in PNS with AKI patients.

Methods:

This study will be a retrospective cohort study of PNS with AKI patients. Renal function recovery and adverse events of the patients receiving Danshen injection(DS group) will be compared with that of the patients with supportive care(SC group) .The study will be conducted using Hospital Information System of the First Affiliated Hospital of Wenzhou Medical University which has longitudinal health information on over 6 million predominantly privately insured individuals and includes over 50 million followup records. The data of inpatients diagnosed with nephrotic syndrome will be reviewed retrospectively. Patients' information includes socio-demographic characteristics, administrative claims (diagnosis and procedure codes), medical histories, laboratory test results and pharmacy claims. PNS wih AKI inpatients will be enrolled. The baseline characteristics will be propensity-score matched. The outcomes are complete and partial renal function recovery for effectiveness analysis and severe bleeding events for safety analysis. Comparisons of cumulative recovery rate will be performed by Kaplan-Meier curves and log-rank test. Risks for outcomes will be assessed using Cox proportional hazard regression models.

Being tested
Dandshen
Keywords
acute kidney injury, nephrotic syndrome, Danshen injection
Medical subject headings
Acute Kidney Injury, Nephrotic Syndrome, Kidney Diseases

What participants receive

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

  • DandshenDrug

    Dandshen injection 20ml /day

Study groups in NCT06071533
Study groupRoleWhat they receive
Danshen Injection(DS group)patients received Danshen Injection
Receives: Drug: Dandshen
Sportive Care group (SC group)patients received sportive care without Danshen Injection

What is being measured

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

  1. complete renal function recovery renal function recovery recovered to normal level

    renal function recovery recovered to normal level

    Measured: 6 months

  2. partial renal function recovery

    Scr has a 30% or greater reduction from peak values,but not to normal level

    Measured: 6 months

Timeline

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

  1. First posted6 Oct 2023
  2. Study start1 Jan 2012
  3. Primary completion30 Dec 2022
  4. Study completion3 Oct 2023

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06071533
Sponsor's protocol ID
KY2023-R157
Status last verified
Oct 2023
First submitted
27 Sep 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Chen T, Zhou Y, Chen X, Chen B, Pan J. Acute kidney injury in idiopathic membranous nephropathy with nephrotic syndrome. Ren Fail. 2021 Dec;43(1):1004-1011. doi: 10.1080/0886022X.2021.1942913.

    PubMed 34157952

  • Lu H, Xiao L, Song M, Liu X, Wang F. Acute kidney injury in patients with primary nephrotic syndrome: influencing factors and coping strategies. BMC Nephrol. 2022 Mar 5;23(1):90. doi: 10.1186/s12882-022-02720-y.

    PubMed 35247980

  • Chen T, Lv Y, Lin F, Zhu J. Acute kidney injury in adult idiopathic nephrotic syndrome. Ren Fail. 2011;33(2):144-9. doi: 10.3109/0886022X.2011.553301.

    PubMed 21332335

  • Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int. 2021 Oct;100(4S):S1-S276. doi: 10.1016/j.kint.2021.05.021. No abstract available.

    PubMed 34556256

  • Lian F, Wu L, Tian J, Jin M, Zhou S, Zhao M, Wei L, Zheng Y, Wang Y, Zhang M, Qin W, Wu Z, Yuan CS, Tong X. The effectiveness and safety of a danshen-containing Chinese herbal medicine for diabetic retinopathy: a randomized, double-blind, placebo-controlled multicenter clinical trial. J Ethnopharmacol. 2015 Apr 22;164:71-7. doi: 10.1016/j.jep.2015.01.048. Epub 2015 Feb 7.

    PubMed 25666427

  • Lyu J, Xue M, Li J, Lyu W, Wen Z, Yao P, Li J, Zhang Y, Gong Y, Xie Y, Chen K, Wang L, Chai Y. Clinical effectiveness and safety of salvia miltiorrhiza depside salt combined with aspirin in patients with stable angina pectoris: A multicenter, pragmatic, randomized controlled trial. Phytomedicine. 2021 Jan;81:153419. doi: 10.1016/j.phymed.2020.153419. Epub 2020 Dec 10.

    PubMed 33360345

  • Zhang Y, Xie Y, Liao X, Jia Q, Chai Y. A Chinese patent medicine Salvia miltiorrhiza depside salts for infusion combined with conventional treatment for patients with angina pectoris: A systematic review and meta-analysis of randomized controlled trials. Phytomedicine. 2017 Feb 15;25:100-117. doi: 10.1016/j.phymed.2017.01.002. Epub 2017 Jan 6.

    PubMed 28190464

  • Lameire NH, Levin A, Kellum JA, Cheung M, Jadoul M, Winkelmayer WC, Stevens PE; Conference Participants. Harmonizing acute and chronic kidney disease definition and classification: report of a Kidney Disease: Improving Global Outcomes (KDIGO) Consensus Conference. Kidney Int. 2021 Sep;100(3):516-526. doi: 10.1016/j.kint.2021.06.028. Epub 2021 Jul 9.

    PubMed 34252450

  • Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

    PubMed 22890468

  • Menon S. Acute Kidney Injury in Nephrotic Syndrome. Front Pediatr. 2019 Jan 14;6:428. doi: 10.3389/fped.2018.00428. eCollection 2018.

    PubMed 30693275

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury and Nephrotic Syndrome, run by First Affiliated Hospital of Wenzhou 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 10 Oct 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

complete renal function recovery renal function recovery recovered to normal level (time frame: 6 months). 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 NCT06071533, which also lists 10 linked publications.

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 10 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in