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Trial record 1 of 2 for:    triptolide ADPKD
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Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Mei changlin, Shanghai Changzheng Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02115659
First Posted: April 16, 2014
Last Update Posted: April 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mei changlin, Shanghai Changzheng Hospital
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Mei changlin, Shanghai Changzheng Hospital:

Primary Outcome Measures:
  • renal volume measured by high resolution magnetic resolution imaging [ Time Frame: 2 yrs ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 14, 2014
First Posted: April 16, 2014
Last Update Posted: April 17, 2014
Last Verified: April 2014

Keywords provided by Mei changlin, Shanghai Changzheng Hospital:
ADPKD
triptolide

Additional relevant MeSH terms:
Triptolide
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Anti-Bacterial Agents
Anti-Infective Agents
Antispermatogenic Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents