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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Shanghai Changzheng Hospital
Sponsor:
Information provided by (Responsible Party):
Mei changlin, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT02115659
First received: April 14, 2014
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Drug: Triptolide-Containing Formulation
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Triptolide-Containing Formulation for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Resource links provided by NLM:


Further study details as provided by Shanghai Changzheng Hospital:

Primary Outcome Measures:
  • renal volume measured by high resolution magnetic resolution imaging [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimated glomerular filtration rate (eGFR) [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]
  • Adverse events. [ Time Frame: 2 yrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Triptolide-Containing Formulation plus standard treatment.

Detailed Description:

Randomized Controlled Trial

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02115659

Contacts
Contact: Changlin Mei, MD chlmei1954@126.com

Locations
China, Shanghai
Shanghai Changzheng Hospital Recruiting
Shanghai, Shanghai, China, 200003
Contact: Changlin Mei, MD       chlmei1954@126.com   
Principal Investigator: Changlin Mei, MD         
Sponsors and Collaborators
Shanghai Changzheng Hospital
Investigators
Principal Investigator: Changlin Mei, MD Shanghai Changzheng Hospital
  More Information

No publications provided

Responsible Party: Mei changlin, Professor,Director of the Kidney Institute, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT02115659     History of Changes
Other Study ID Numbers: CZKIPLA-ADPKD-002
Study First Received: April 14, 2014
Last Updated: April 16, 2014
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai Changzheng Hospital:
ADPKD
triptolide

Additional relevant MeSH terms:
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Kidney Diseases
Urologic Diseases
Kidney Diseases, Cystic
Triptolide
Antispermatogenic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014