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

NCT02115659 | Unknown Phase 3 DMC

• 1 other identifier: CZKIPLA-ADPKD-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Keywords

ADPKD; triptolide

Outcome Measures

Primary Outcomes (1)

• renal volume measured by high resolution magnetic resolution imaging

  2 yrs

Secondary Outcomes (2)

• Estimated glomerular filtration rate (eGFR)

  2 yrs

• Adverse events.

  2 yrs

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Triptolide-Containing Formulation

EXPERIMENTAL

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

Drug: Triptolide-Containing Formulation

Interventions

Triptolide-Containing Formulation DRUG

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.

Also known as: Triptolide-Containing Formulation plus standard treatment.

Triptolide-Containing Formulation

Placebo DRUG

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

Also known as: Placebo plus standard treatment.

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Changlin Mei, MD

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changlin Mei, MD

CONTACT

chlmei1954@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,Director of the Kidney Institute

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

CN (1)