INTERNATIONAL RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF KIACTATM IN PREVENTING RENAL FUNCTION DECLINE IN PATIENTS WITH AA AMYLOIDOSIS
- Registration Number
- PER-012-11
- Lead Sponsor
- AUVEN THERAPEUTICS (A.T Development Switzeriand SARL).,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 17
A) PATIENTS MUST BE AT LEAST 18 YEARS OF AGE AND NO MORE THAN 80 YEARS OF AGE.
B) PATIENTS ARE MALES OR NONPREGNANT, NONLACTATING FEMALES.
- WOMEN MUST BE OF NONCHILDBEARING POTENTIAL (IE, MORE THAN 1 YEAR POSTMENOPAUSAL) OR USE EFFECTIVE CONTRACEPTION FOR AT LEAST 2 MONTHS PRIOR TO THE BASELINE VISIT AND THROUGH 30 DAYS AFTER THE LAST DOSE OF STUDY MEDICATION AS FOLLOWS:
I. ORAL CONTRACEPTION WITH AN ADDITIONAL BARRIER METHOD (SINCE THE INVESTIGATIONAL PRODUCT MAY IMPAIR EFFECTIVENESS OF ORAL CONTRACEPTION)
II.DOUBLE-BARRIER METHOD (DIAPHRAGRN WITH SPERMICIDAL GEL OR CONDOM WITH CONTRACEPTIVE FOAM)
III. TRANSDERMAL OR LONG-ACTING INJECTED CONTRACEPTIVE (EG, DEPOT MEDROXYPROGESTERONE ACETATE [DEPO-PROVERA®])
IV. INTRAUTERINE DEVICE OR IMPLANTABLE CONTRACEPTIVE
V. PARTNER WHO IS SURGICALLY STERILE (VASECTOMY)
VI. TOTAL ABSTINENCE.
- A WOMAN OF CHILDBEARING POTENTIAL MUST HAVE A NEGATIVE SERUM PREGNANCY TEST AT THE FIRST SCREENING VISIT. URINE PREGNANCY TESTS WILL ALSO BE PERFORMED AT EVERY SUBSEQUENT VISIT. SHOULD A PATIENT BECOME PREGNANT DURING THE STUDY, STUDY MEDICATION WILL BE DISCONTINUED AND THE PATIENT WILL BE WITHDRAWN FROM THE STUDY AND FOLLOWED-UP BY RESEARCH PERSONNEL UNTIL DELIVERY.
A) EVIDENCE OR SUSPICION OF CHRONIC KIDNEY DISEASE SECONDARY TO A DISEASE PROCESS OTHER THAN RENAL AA AMYLOIDOSIS (EG, DIABETES, LONG-STANDING UNCONTROLLED HYPERTENSION, POLYCYSTIC KIDNEY DISEASE, RECURRING POLYNEPHRITIS, OR SYSTEMIC LUPUS ERYTHEMATOSUS).
B) HISTORY OF KIDNEY TRANSPLANTATION.
C) EVIDENCE OR SUSPICION OF A CAUSE OF POTENTIALLY REVERSIBLE ACUTE RENAL FAILURE, SUCH AS UNCONTROLLED HYPERTENSION, URINARY TRACT INFECTION, OR DRUG NEPHROTOXICITY WITHIN 3 MONTHS PRIOR TO THE BASELINE VISIT.
D) PRESENCE OF CONCOMITANT DISEASES OR CONCOMITANT MEDICATION THAT COULD INTERFERE WITH THE INTERPRETATION OF STUDY RESULTS OR COMPROMISE PATIENT SAFETY. TO BE RECONFIRMED AT THE BASELINE VISIT.
E) PRESENCE OF CONDITIONS THAT COULD REDUCE LIFE EXPECTANCY TO LESS THAN 2 YEARS. TO BE RECONFIRMED AT THE BASELINE VISIT.
F) PRESENCE OF TYPE 1 OR TYPE 2 DIABETES MELLITUS.
G) PRESENCE OF SIGNIFICANT HEPATIC ENZYME ELEVATION OR CIRRHOSIS. SIGNIFICANT HEPATIC ENZYME ELEVATION DEFINED BY ANY OF THE FOLLOWING:
• ASPARTATE AMINOTRANSFERASE >5 TIMES THE UPPER LIMIT OF NORMAL (ULN)
• ALANINE AMINOTRANSFERASE >5 TIMES THE ULN
• ALKALINE PHOSPHATASE >5 TIMES THE ULN
• TOTAL BILIRUBIN >50% ABOVE THE ULN.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method