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

April 16, 2014 updated by: Mei changlin, Shanghai Changzheng Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Randomized Controlled Trial

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200003
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo plus standard treatment. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain.
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.
Other Names:
  • Placebo plus standard treatment.
EXPERIMENTAL: Triptolide-Containing Formulation
Triptolide-Containing Formulation (1mg/kg/d) was prescribed; Dosage will be adjusted if necessary according to the adverse events monitoring.
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.
Other Names:
  • Triptolide-Containing Formulation plus standard treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
renal volume measured by high resolution magnetic resolution imaging
Time Frame: 2 yrs
2 yrs

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimated glomerular filtration rate (eGFR)
Time Frame: 2 yrs
2 yrs
Adverse events.
Time Frame: 2 yrs
2 yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

May 1, 2016

Study Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

April 14, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (ESTIMATE)

April 16, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 17, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZKIPLA-ADPKD-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe