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

Randomized Controlled Trial of Triptolide-Containing Formulation for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02115659

Enrollment

100

Registered

2014-04-16

Start date

2014-04-30

Completion date

2016-05-31

Last updated

2014-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Keywords

ADPKD, triptolide

Brief summary

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.

Detailed description

Randomized Controlled Trial

Interventions

DRUGTriptolide-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.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
renal volume measured by high resolution magnetic resolution imaging	2 yrs

Secondary

Measure	Time frame
Estimated glomerular filtration rate (eGFR)	2 yrs
Adverse events.	2 yrs

Countries

China

Contacts

Primary ContactChanglin Mei, MD

chlmei1954@126.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026