Renal Anemia

January 8, 2018

Akebia Therapeutics announced positive top-line results from its Phase II study of vadadustat in patients with anemia associ­ated with dialysis-dependent chronic kidney disease (DD-CKD) in Japan. The results are consistent with findings from previous stud­ies of vadadustat. Akebia’s partner, Mitsubi­shi Tanabe Pharma Corporation (MTPC), is conducting a Phase III study of non-dialysis dependent (NDD-CKD) patients in Japan and, based upon the data, is expected to begin Phase III studies in DD-CKD patients in Japan in 2018. The double-blind, placebo-controlled, dose-finding Phase II study was designed to evaluate the efficacy, safety and tolerability of orally-administered vada­dustat in Japanese patients with anemia associated with DD-CKD. This 16-week study evaluated 60 patients during a six-week placebo-controlled, fixed-dose period and a 10-week active treatment, dose adjust­ment and maintenance period. The primary efficacy endpoint was mean hemoglobin change from baseline to week six comparing vadadustat to placebo. Statistically significant improvements in the primary endpoint were observed in the vadadustat groups, 150mg (p=0.0004), 300mg (p<0.0001) and 600mg (p<0.0001), compared to placebo. The data indicate a dose-response for vadadustat.

November 21, 2011

AMAG Pharmaceuticals issued results from a phase II trial of ferumoxytol for the treatment of iron deficiency anemia and chronic kidney disease. This randomized, active controlled trial, FIRST, enrolled 162 subjects who received an intravenous infusion of ferumoxytol for a total cumulative dose of 1.02 g or an intravenous infusion of iron sucrose for a total cumulative dose of 1.0 g. The subjects treated with ferumoxytol had a comparable increase in hemoglobin (Hgb) at Week 5 from baseline compared with subjects treated with iron sucrose, however, higher Hgb values were observed at all time points following treatment through Week 5 in the ferumoxytol-treated arm compared to the iron sucrose arm. Of the subjects treated with ferumoxytol, 50% achieved a ≥1 g/dL increase in Hgb compared with 42% of subjects treated with iron sucrose. In addition, subjects treated with ferumoxytol had a faster time to response, 28.5 days versus 32.9 days. Ferumoxytol treatment resulted in lower overall rates of adverse events and related adverse events.

FibroGen released interim results from a phase IIb trial of FG-4592 for the treatment of anemia resulting from chronic kidney disease. This randomized, open-label, comparator-controlled study, FG-4592-041, is evaluating several treatment options of FG-4592 for a 16 or a 24 week period. Data are from the first four treatment arms and include 96 subjects with chronic kidney disease who are not on dialysis. Treatment with FG-4592 was designed to increase hemoglobin (Hb) by at least 1 g/dL and maintain Hb concentration in the target range of 11-13 g/dL for the first two arms (arms A and B) treated for 16 weeks, and 10.5-12.0 g/dL in the second two arms (arms C and D) treated for 24 weeks. Results showed that during the treatment period, 96% of all subjects had an increase in Hb of at least 1 g/dL, and 93% had an Hb response. The response rate was 83% in Arm A, which used three times weekly dosing throughout the study, with dose-adjustment decisions made monthly. In Arm B the response rate was 100%; this arm used weight-adjusted initial doses of FG-4592 administered three times weekly during the Hb correction phase, followed by twice weekly dosing during the Hb maintenance phase. The response rate was 91% in Arm C, which used a fixed starting dose of 50 mg thrice weekly. In arm D the response rate was 96%; this arm used a fixed starting dose of 100 mg for four weeks after which dose adjustments were made every four weeks.

October 11, 2010

Akebia reported positive results from a phase IIa trial of AKB-6548 for the treatment of anemia due to chronic kidney disease. This U.S-based, open label trial enrolled 22 subjects with stage 3 and 4 chronic kidney disease. The subjects received a single, oral dose of AKB-6548 and erythropoietin (EPO) levels were measured at eight, 12 and 24 hours post-administration. AKB-6548 resulted in significantly increased EPO levels eight and 12 hours post administration, with levels returning to baseline within 24 hours, supporting the potential of once daily dosing. The compound was found to be safe, with no serious adverse events.

April 30, 2007

Roche positive results from two phase III trials, (MAXIMA and PROTOS) of Mircera, for the treatment of renal anemia in elderly patients with chronic kidney disease. These trials enrolled a total of 1,245 dialysis subjects with a mean age of 60 years. Subjects were randomized to remain on their current epoetin treatment administered up to three times or week or to be switched directly to Mircera administered intravenously (IV) or subcutaneously (SC) once every two weeks or once every four weeks. Results revealed that Mircera IV and SC maintained stable hemoglobin (Hb) levels in the group switched from epoetin alpha and beta, deviating less than 0.5 g/dL from the start of the trial. Minimal changes from baseline to evaluation in mean Hb levels were seen in subjects less than or equal to 65 and over 65 years (-0.18 vs -0.34 g/dL). A BLA and MAA for Mircera are currently under review by the FDA and EMEA, respectively.

November 21, 2005

Roche issued positive results of a phase II extension study of CERA for the treatment of anemia in chronic kidney disease (CKD) patients not yet on dialysis. Weekly (11.3 g/dL), once-every-two-weeks (11.4g/dL) and once- every-three week (11.7 g/dL) doses of the drug met their primary efficacy endpoint of maintaining hemoglobin levels between 11 and 12 g/dL throughout the treatment period. The drug was generally well tolerated: the most frequently reported adverse events were urinary tract infections, gout, hypertension, peripheral edema, and insomnia. This open-label study enrolled 51CKD patients, who received treatment with subcutaneous doses of CERA once weekly, once every 2 weeks or once every 3 weeks for 54 weeks.

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