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

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02115659
• Other study ID #: CZKIPLA-ADPKD-002
• Status: Recruiting
• Phase: Phase 3
• First received: April 14, 2014
• Last updated: April 16, 2014
• Start date: April 2014
• Est. completion date: May 2016

Study information

• Verified date: April 2014
• Source: Shanghai Changzheng Hospital
• Contact: Changlin Mei, MD
• Email: chlmei1954[@]126.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

Description:

Randomized Controlled Trial

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal volume measured by high resolution magnetic resolution imaging		2 yrs	No
Secondary	Estimated glomerular filtration rate (eGFR)		2 yrs	Yes
Secondary	Adverse events.		2 yrs	Yes