None listed
Conditions
Interventions
PATIENTS DIAGNOSED WITH AA AMYLOIDOSIS WILL BE RANDOMLY ASSIGNED AT A 1:1 RATIO TO RECEIVE EITHER KIACTA OR PLACEBO. RANDOMIZATION WILL BE STRATIFIED BY AVERAGED SCREENING PROTEINURIA (< 3 or ≥
3 g/day) AND AVERAGED SCREENING eGFR ( < 60 or ≥
60 mL/min/1.73 m²).
PATIENTS WIIL BE ASSESSED AS FOLLOWS:
. TWICE DURING THE SCREENING PERIOD (MONTH -3 TO WEEK -1)
. AT BASELINE
. EVERY 3 MONTHS UNTIL ONE OF THE FOLLOWING HAS OCCURRED OR FOR PATIENTS WHO DISCONTINUE:
O ESRD HAS BEEN CONFIRMED BY ADJUDICATION,
O THE CrCl OR Scr COMPONENT OF THE PRIMARY ENDPOINT HAS BEEN
PATIENTS WHO DISCONTINUE WILL BE ASKED TO ATTEND IONG-TERM FOLLOW-UP EVERY 3 MONTHS UNTIL THE PRESENCE OF STAGE 5 CHRONIC KIDNEY DISEASE, INITIATION OF PERMANENT RENAL REPLACEMENT THERAPY OR TRANSPLAN
. FOR ALL PATIENTS WHO REMAIN ON TREATMENT AT THE END OF THE STUDY, AT THE END-OF-STUDY VISIT
. FOR ALL PATIENTS ENROLLED IN THE STUDY, SURVIVAL ASSESSMENT AND RENAL FUNCTION STATUS (IE, PRESENCE OF STAGE 5 CHRONIC KIDNEY DISEASE, INITIATION OF PERMANENT RENAL REPLACEMENT THERAPY) AT THE END O
Sponsors
AUVEN THERAPEUTICS (A.T Development Switzeriand SARL).,
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 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 SHOULD A PATIENT BECOME PREGNANT DURING THE STUDY, STUDY MEDICATION WILL BE DISCONTINUED AND THE PATIENT WILL BE WITHDRAWN FROM THE STUDY AND FOLLOWED-UP BY RESEARCH PERSONNEL UNTIL DELIVERY.
Exclusion criteria
Exclusion criteria: 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.
Countries
Argentina, Belgium, Brazil, Bulgaria, Chile, Czech Republic, Egypt, Estonia, Finland, France, Georgia, Germany, India, Israel, Italy, Lithuania, Mexico, Netherlands, Peru, Poland, Russian Federation, Spain, Sweden, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactAndres Cesar Martin Bayona
PPD Peru S.A.C.
Outcome results
None listed