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Trial record 22 of 110 for:    "polycystic kidney disease"

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

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ClinicalTrials.gov Identifier: NCT02115659
Recruitment Status : Unknown
Verified April 2014 by Mei changlin, Shanghai Changzheng Hospital.
Recruitment status was:  Recruiting
First Posted : April 16, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Mei changlin, Shanghai Changzheng Hospital

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.

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

Detailed Description:
Randomized Controlled Trial

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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)
Study Start Date : April 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 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.




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
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

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

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 Posted: April 16, 2014    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: April 2014

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

Additional relevant MeSH terms:
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Kidney Diseases
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Anti-Bacterial Agents
Triptolide
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