Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Triptolide was shown in experimental studies to inhibit the cyst formation and growth in ADPKD models, while triptolide-containing formulation was revealed to potentially slow the disease progression in several proteinuric ADPKD patients in our clinical practice. It remains to be shown the effect of triptolide-containing formulation on total kidney volume (TKV) enlargement and renal function protection in ADPKD patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

NCT01280721

Autosomal Dominant Polycystic Kidney Disease （ADPKD)

COMPLETED PHASE3

Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD

NCT01210560

Autosomal Dominant Polycystic Kidney Disease

COMPLETED PHASE2

Evaluation of Effect of TRC101 on Progression of Chronic Kidney Disease in Subjects With Metabolic Acidosis

NCT03710291

Metabolic Acidosis Chronic Kidney Disease

TERMINATED PHASE3

Study of Tamibarotene in Patients With ADPKD

NCT06289998

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

ACTIVE_NOT_RECRUITING PHASE2

Tolvaptan Extension Study in Participants With ADPKD

NCT01214421

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Randomized Controlled Trial

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Placebo plus standard treatment. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain, etc.

Triptolide-Containing Formulation

Triptolide-Containing Formulation (1mg/kg/d) was prescribed; Dosage will be adjusted if necessary according to the adverse events monitoring.

Group Type EXPERIMENTAL

Triptolide-Containing Formulation

Intervention Type DRUG

Triptolide-Containing Formulation (1mg/kg/d) plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Triptolide-Containing Formulation

Triptolide-Containing Formulation (1mg/kg/d) plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain.

Intervention Type DRUG

Placebo

Placebo plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain, etc.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Triptolide-Containing Formulation plus standard treatment. Placebo plus standard treatment.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ADPKD patient older then 40 years of age without gender limitation
* Estimated glomerular filtration rate (eGFR) higher than 60 ml/min 1.73m2
* documented kidney volume progression with yearly increasing rate more than 6%
* informed consent

Exclusion Criteria

* Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception
* impaired liver function as increased liver enzymes (2-fold above normal values)
* uncontrolled hypercholesterolemia (fasting cholesterol \> 8 mmol/l) or hypertriglyceridaemia (\> 5 mmol/l) under lipid lowering therapy
* granulocytopenia (white blood cell \< 3,000/mm3) or thrombocytopenia (platelets \< 100,000/mm3)
* hepatitis B or C, HIV infection
* malignancy
* mental illness that interfere with the patient ability to comply with the protocol
* drug or alcohol abuse
* known hypersensitivity to similar drugs as Triptolide-Containing Formulation

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No