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Trial record 12 of 42 for:    "Autosomal dominant polycystic kidney disease"
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Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00920309
First received: June 12, 2009
Last updated: June 28, 2010
Last verified: June 2010
History of Changes
  Purpose

Currently the only approved use for rapamycin (sirolimus) is for immunosuppression after renal transplantation.

This trial is designed to determine whether rapamycin is safe and effective treatment for patients with polycystic kidney disease (ADPKD). Patients will be followed by volumetric magnetic resonance imaging (MRI) to observe for change in kidney (and cyst) size. Blood and urine samples will also be collected to evaluate for change in biomarkers with treatment.


Condition Intervention Phase
Autosomal Dominant Polycystic Kidney Disease
 Drug: Rapamycin
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rapamycin as Treatment for ADPKD: The Role of Biomarkers in Predicting a Response to Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • combined kidney volume [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • kidney function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • change in biomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rapamycin
    The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml.
    Other Name: sirolimus
Detailed Description:

This is a 2 year, open label trial to evaluate the role of rapamycin as treatment for ADPKD. Patients will be randomized 2:1 to the rapamycin arm or to standard therapy. The dose of rapamycin will be adjusted so that patients obtain 24 trough levels of 4-6ng/ml. There will be a volumetric MRI measurement at the start and end of the treatment period. Patients will be monitored every 4 months throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult ADPKD patients aged 18-70
  • combined kidney volume >1200 ml
  • estimated creatinine clearance >60 ml/min
  • absence of implanted ferromagnetic objects

Exclusion Criteria:

  • Age >70
  • uncontrolled hyperlipidemia
  • Proteinuria >500 mg/day
  • unstable cerebral aneurysm
  • active coronary artery disease
  • diagnosis of another systemic condition affecting kidney function (ie: diabetes, hepatitis B or C, HIV)
  • diagnosis of cancer other than skin cancer
  • pregnancy or lactation
  • presence of implanted ferromagnetic objects
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920309

Locations
United States, Connecticut
Yale Center for Clinical Investigation Recruiting
New Haven, Connecticut, United States, 06520
Contact: Neera K Dahl, MD, PhD     203-785-4184     neera.dahl@yale.edu    
Contact: Tammy Stalmack, Study Coordinator     203-737-1575        
Principal Investigator: Neera K Dahl, MD, PhD            
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Neera K Dahl, MD, PhD Yale University
  More Information

No publications provided

Responsible Party: Dr. Neera Dahl, Yale University School of Medicine, Section of Nephrology
ClinicalTrials.gov Identifier: NCT00920309     History of Changes
Other Study ID Numbers: HIC#0903004934
Study First Received: June 12, 2009
Last Updated: June 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Autosomal Dominant Polycystic Kidney Disease
rapamycin
ADPKD

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013