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

Primary Purpose

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Triptolide-Containing Formulation
Placebo
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease (ADPKD) focused on measuring ADPKD, triptolide

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai Changzheng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Triptolide-Containing Formulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

renal volume measured by high resolution magnetic resolution imaging

Secondary Outcome Measures

Estimated glomerular filtration rate (eGFR)
Adverse events.

Full Information

First Posted
April 14, 2014
Last Updated
April 16, 2014
Sponsor
Shanghai Changzheng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02115659
Brief Title
Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Official Title
Randomized Controlled Trial of Triptolide-Containing Formulation for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Changzheng Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Keywords
ADPKD, triptolide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo plus standard treatment. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain.
Arm Title
Triptolide-Containing Formulation
Arm Type
Experimental
Arm Description
Triptolide-Containing Formulation (1mg/kg/d) was prescribed; Dosage will be adjusted if necessary according to the adverse events monitoring.
Intervention Type
Drug
Intervention Name(s)
Triptolide-Containing Formulation
Other Intervention Name(s)
Triptolide-Containing Formulation plus standard treatment.
Intervention Description
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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo plus standard treatment.
Intervention Description
Placebo plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain, etc.
Primary Outcome Measure Information:
Title
renal volume measured by high resolution magnetic resolution imaging
Time Frame
2 yrs
Secondary Outcome Measure Information:
Title
Estimated glomerular filtration rate (eGFR)
Time Frame
2 yrs
Title
Adverse events.
Time Frame
2 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changlin Mei, MD
Email
chlmei1954@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD
Email
chlmei1954@126.com
First Name & Middle Initial & Last Name & Degree
Changlin Mei, MD

12. IPD Sharing Statement

Learn more about this trial

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

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