- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00571909
Autosomal Dominant Polycystic Kidney Disease (ADPKD) Pain Study
Evaluation and Treatment of Chronic Pain in Autosomal Dominant Polycystic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Some patients with autosomal dominant polycystic kidney disease (ADPKD) have intractable disabling chronic kidney pain. Among methods used to manage these patients, removal of the nerve supply to the kidney by Videothoracoscopic excision of Splanchnic nerve (videothoracoscopic splanchnicectomy - VSPL) is one of the most promising procedures. Few of these procedures have been performed in ADPKD patients (and in only one patient using the less invasive thoracic approach). We recently performed VSPL on two patients who had chronic pain. Both had initial improvement but have had very short follow up. This study should improve understanding of the molecular mechanisms and mediators of kidney pain and provide the hope of an effective procedure to ADPKD patients with chronic kidney pain.
We are now enrolling patients to study the effectiveness of the VSPL operation, collecting information on pain intensity, quality of life, kidney blood flow, kidney/cyst volume and also to study the involved pain pathways.
Baseline Visit - The patient will also have a complete physical exam and have the kidney's filtration rate measured. Urine and blood tests are performed at each evaluation. You will have an MRI performed of your kidneys. There is no radiation exposure associated with this procedure. You will also be asked to complete Quality of Life (QOL), HALT Pain, and Depression Score questionnaires. These will take approximately 15 minutes to complete and will be repeated at each evaluation.
The VSPL operation will be done within approximately 1 week of your Baseline Visit and is considered part of your clinical care and not part of the research.In this procedure the surgeon approaches the nerves supplying the kidneys through the chest wall, using 3 small incisions. He locates these nerves, then cuts a piece of them and removes it from the chest cavity.You will be released from the hospital when your pain is controlled on oral medications.
1 Month Visit-You will be asked to return to the Mayo Clinic one month after your VSPL procedure for a physical exam and completion of the questionnaires.If unable to return to the Mayo Clinic this evaluation can be done with your local doctor.
3 Month Visit-The 3 Month Visit will be identical to the Baseline visit. You will have a physical exam, blood and urine samples, MRI of your kidneys, Iothalamate Clearance, and the three questionnaires to complete.
6 Months: The questionnaires will be mailed to you for completion.
12 Month Visit-The 12 Month Visit is identical to the 1 Month visit. You will be asked to return to the Mayo Clinic for a physical exam and completion of the questionnaires.
2 Year Visit-The 2 Year Visit will be identical to the Baseline visit. You will have a physical exam, blood and urine samples, MRI of your kidneys, measurement of kidney filtration and complete the three questionnaires.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older
- Diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- History of debilitating kidney pain for at least 6 month. Other methods of pain management will have been appropriately considered and used when feasible and indicated.
- Patient fit for general anesthesia
- Must be able to travel to Mayo Clinic Rochester for 3 visits
- Must be able to cover the cost of the surgery and post operative care.
Exclusion Criteria:
- Pregnant women (must have a confirmed negative pregnancy test)
- Nursing women
- Creatinine > 3mg/dl, or hemodialysis dependent
- Cancer and other major systemic diseases that could prevent follow-up or data interpretation
- Neurologic or psychologic conditions preventing appropriate informed consent
- Uncontrolled hypertension(SBP > 160; DBP >100)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: video thoracoscopic splanchnicectomy (VSPL)
|
VSPL is a minimally invasive technique using 1-2cm incisions through which a camera and surgical tools are placed inside the thoracic cavity and the idea of the procedure is to cut the pain pathway linking the splanchnic ganglion with pain centers in the hypothalamus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in pain control and quality of life
Time Frame: 2 yrs
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2 yrs
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in urine biomarkers compared to pre-operation values within patients will be compared. Changes in kidney volume, kidney cyst volume, and kidney blood flow before and after the operation will be studied.
Time Frame: 3 years
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3 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Marie C. Hogan, M.D., Ph.D., Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Musculoskeletal Abnormalities
- Abnormalities, Multiple
- Kidney Diseases, Cystic
- Ciliopathies
- Kidney Diseases
- Polycystic Kidney Diseases
- Polycystic Kidney, Autosomal Dominant
- Arthrogryposis
Other Study ID Numbers
- 06-009690
- PDK#14 (Other Grant/Funding Number: Polycystic Kidney Disease Foundation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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