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Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis Clinical research trials and Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis. Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis clinical trial. Participants typically obtain the most effective healthcare available for their Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis  Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
For Condition: Secondary (AA) Amyloidosis,Rheumatoid Arthritis,Familial Mediterranean Syndrome,Gastrointestinal Diseases,Kidney Diseases,Nephrotic Syndrome
Status: No longer recruiting
Sponsor(s): Neurochem Inc. , FDA Office of Orphan Products Development
Synopsis: The main objective of this study is to evaluate the safety and efficacy of NC-503 compared to placebo in patients with secondary (AA) amyloidosis using a composite assessment of clinical improvement/worsening of both renal and gastrointestinal functions.
Details: AA amyloidosis is associated with chronic inflammatory conditions (rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease), chronic infection (tuberculosis, osteomyelitis), and Familial Mediterranean Fever. Rheumatoid arthritis is the major cause of AA amyloidosis in Western Europe and North America. The most common clinical feature of AA amyloidosis is renal dysfunction manifested as nephrotic-range proteinuria or renal insufficiency at the time of diagnosis. End-stage renal failure is the cause of death in 40-60% of cases. Gastrointestinal involvement is also frequent and is usually manifested as chronic diarrhea, body weight loss and malabsorption. Enlargement of the liver and spleen may also occur in some patients. The median survival time from diagnosis varies from 2 to 8 years depending on the stage of the disease at time of diagnosis. The goal of the current therapy in AA amyloidosis is the control of the associated disease. However, the current approaches for the treatment of AA amyloidosis are unspecific, toxic, invasive, and not sufficiently effective in many cases. NC-503 was specifically designed to compete with the naturally occurring sulfated GAGs for the binding to amyloidogenic precursor proteins, and to inhibit amyloid deposition into tissues. The proposed therapy with NC-503 is based on the prevention of the amyloid fibril formation. The objective of this clinical phase II/III study is to determine the efficacy and safety of NC-503 compared to a placebo in patients suffering from secondary (AA) amyloidosis by the assessment of clinical improvement/ worsening of both renal and gastrointestinal functions.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL INCLUSION CRITERIA - Patients must be 18 years of age or older. - Males and females. If women of childbearing potential (i.e., not surgically sterilized or post-menopausal greater than one year) the patient must be using effective birth control. - Diagnosis of AA amyloidosis demonstrated by positive biopsy (Congo red staining) and immunohistochemistry or immunoelectron microscopy at screening visit. Tissue from previous biopsy can be used for confirmation of diagnosis, if available. - Persistent proteinuria defined as urinary protein excretion ? 1g/24h in two distinct 24-h urine collections at least 1 week apart within 3 months prior to study entry (baseline, Month 0 visit) without evidence of urinary tract infection or overt heart failure (NYHA class III or more); OR creatinine clearance ? 60 mL/min in two distinct measures at least 1 week apart within 3 months prior to study entry (baseline, Month 0 visit). - Creatinine clearance ? 20 mL/min AND serum creatinine ? 3 mg/dl within 3 months prior to study entry (baseline, Month 0 visit). - Written informed consent. PROTOCOL EXCLUSION CRITERIA - Evidence or suspicion of renal or renovascular diseases other than renal AA amyloidosis. - Presence of diabetes mellitus (Type I and II). - Evidence of a cause of potentially reversible reduced renal function, such as accelerated hypertension or drug nephrotoxicity. - AST, ALT, or ALP > 5 times the upper limit of normal, or total bilirubin 50% above upper limits of normal. - Presence of any other clinically significant diseases that could interfere with the interpretation of study results or compromise patient safety or any conditions that could reduce life expectancy to less than two years. - Use of an investigational drug within thirty days prior to the screening visit. - Active alcohol and/or drug abuse. - Initiation of or any changes in ACE inhibitor therapy within 3 months prior to the screening visit. - Initiation of or any changes in cytotoxic agents/colchicine therapy within 3 months prior to the screening visit. - Inability to provide legal consent.
Total Enrollment: 150
Location and Contact Information:
Italian Group for Systemic Amyloidosis, Biotechnology Research Laboratories, IRCCS Policlinico San Matteo, Internal Medicine and Medical Oncology
Pavia, , 27100
Italy
Marmara University Medical School Hospital, Department of Rheumatology
Uskudar, Altunizade, Istanbul, , 81190
Turkey
University Hospital Groningen, Department of Medicine, Division of Rheumatology
Groningen, , 9700 RB
Netherlands
Regional Hospital No. 1
Yekaterinburg, , 320102
Russian Federation
Ciutad Sanità ria y Università ria de Bellvitge, Servicio de Reumatologia, Hospitalet de Llobregat
Llobregat, , 08907
Spain
Hôpital Cochin, Centre de Recherche et d'Explorations Fonctionnelles
Paris, , 75679 CEDEX 14
France
Gartnavel General Hospital
Scotland, , G12 0YN
United Kingdom
Institute of Rheumatology RAMS
Moscow, , 115522
Russian Federation
Centre Hospitalier du Mans, Service de Rhumatologie
Le Mans, , CEDEX 1
France
Boston Medical Center, Renal Division
Boston, Massachusetts, 02118
United States
Hospital Clinico San Carlos de Madrid, Servicio de Reumatologia
Madrid, , 28040
Spain
Hospital Clinic I Provincial de Barcelona, Jefe del Departamento de Reumatologia
Barcelona, , 08036
Spain
Cerrehpasa Tip Fakultesi
Askaray, Istanbul, Turkey, ,
Turkey
Heller Institute of Medical Research, Sheba Medical Center
Tel Hashomer, , 52621
Israel
Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology
Istanbul, , 34390 CAPA
Turkey
Vilnius University Hospital
Vilnius, , 2001
Lithuania
Mount Sinai Medical Center
New York City, New York, 10029
United States
Royal Free and University College Medical School, Department of Medicine, National Amyloidosis Centre
London, , NW3 2PF
United Kingdom
Instytut Reumatologiczny
Warszawa, , 02-632
Poland
Rheumatism Foundation Hospital
Heinola, , FIN-18120
Finland
Hospital Universitario Germans Trias I Pujol, Servicio de Reumatologia
Badalona, , 08916
Spain
Bnai Zion Medical Center
Haifa, , 31048
Israel
Mayo Clinic
Rochester, Minnesota, 55905
United States
Indiana University School of Medicine, Department of Pathology and Laboratory Medicine,
Indianapolis, Indiana, 46202
United States
Okregowy Szpital Kolejowy, Zaklad Reumatologii
Wroclaw, , 53-137
Poland
Hôpital Claude Huriez, Service de médecine Interne, Clinique Médicale A
Lille, , CEDEX 59037
France
Additional Information:
Study ID Numbers: CL-503004;
Study Start Date: October 2001
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035334
Other Familial Mediterranean Syndrome Studies:
1. Dynamic Aspects of Amino Acid Metabolism
2. Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
3. A Trial of Carboxypeptidase-G2 (CPDG2) and Thymidine for the Management of Patients with Methotrexate Toxicity and Renal Dysfunction
4. Endolymphatic Sac Tumors in a Population of Patients with von Hippel-Lindau Disease:The Natural History and Pathobiology, and a Prospective Non-Randomized Clinical Trial of Hearing Preservation Surgery in Patients with Early Stage Endolymphatic Sac Tumors
5. Omega-3 Fatty Acids that Affect the Immune System in Kidney Transplant Patients
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Study of the Safety and Efficacy of NC-503 in Secondary (AA) Amyloidosis
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