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Table 4 Anemia correction studies

From: Erythropoiesis stimulating agents and reno-protection: a meta-analysis

Reference

Study Location

ESA

Duration of Therapy

Comparator Arm

Subjects (Total and # in groups)

Starting vs Achieved Hb High(H) or low(L) Hb Group (g/dL)

Other Renal Outcomes

Abraham 1990 [38]

Hennepin County Medical Center Minneapolis Minn (USA)

Epoetin α (50–150 U/Kg 3X/w) to raise Hct to 37% vs 29%.

8–12 weeks to raise Hct then patients received ESA

Placebo (unspecified)

N = 8: ESA(4), control(4)

L: 9.3 vs 9.7

H: 10.7 vs 12.3

After 18 weeks there was no difference in the 1/sCr curves and no difference in protein excretion

Clyne 1992 [39]

Karolinska Hospital, Danderyd Hospital Stockholm (Sweden)

Epoetin β (300 U/kg) 1X/week to raise Hb from 8.6 to 11.7 g/dL

12 weeks

Placebo (unspecified)

N = 22: ESA(12), control(10)

L: 9.3 vs 9.4

H: 8.7 vs 11.3

No change in eGFR in either group. No significant difference in change in sCr

Kleinman 1989 [40]

Valley Presbyterian hospital, Van Nuys California (USA)

ESA (100 U/kg, 3x/week) to raise hct from 28 to 38–40%

12 weeks

Placebo (unspecified)

N = 14: ESA(7), control(7)

L: 9.4 vs 9.4

H: 9.4 vs 11.9

No difference in sCr or change in sCr

Kuriyama 1997 [41]

Saiseikai Central hospital, Tokyo Japan

Epoetin β (6000 U/week) to raise hct from 25.5 to 35.5%

36 weeks

No ESA

N = 108: ESA(42), control(66)

L: 9.3 vs 8.4

High Hb control

12.0 vs 10.7

H: 9.0 vs 11.8

Time to a doubling in sCr significantly slower in the ESA group.

Lim 1989 [42]

University of Iowa Hospitals’ Renal Clinic, Iowa (USA)

ESA (50, 100, or 150 U/kg 3X/week)

8 weeks

Placebo (unspecified)

N = 13: ESA(11), control(2)

L: 9,0 vs 12.7

H: 9.0 vs 8.0

No change in renal function over 2 months in ESA group

Lim 1990 [43]

University of Iowa Hospitals’ Renal Clinic, Iowa (USA)

Epoetin α 3X/week, later switched to 1X/week to raise Hct from 28 to 36%

11.8 ± 6.8 months (range 2.8-23.8)

No ESA

N = 20: ESA(10), control(10)

L: 11.0 vs 9.0

H: 9.3 vs 12.0

The rate of change in sCr was similar over 12 months

Revicki 1995 [18]

USA

Epoetin α (50 U/kg, 3X/week) then titrated to increase Hct from 27 to 35%.

48 weeks

No ESA

N = 83: ESA(43), control(40)

L: 8.9 vs 8.6

H: 8.9 vs 10.5

No difference in change in eGFR after 48 weeks, no difference in time to dialysis

Akizawa 2011 [44]

Japan

Darbepoetin alfa (30 ug 1X/week) to target Hb 11–13 g/dL.

48 weeks

rHuEpo (~4000 U/week) to maintain Hb at 9–11 g/dL. All received at least one dose of ESA

N = 321: High Hb (161), Low Hb (160)

L: 9.2 vs 10.1

H: 9.2 vs 11.9

No difference in 2 years decline in eGFR

Cianciaruso 2008 [45]

Italy

Epoetin α (2000 U 1x/week) to maintain Hb at 12–14 g/dL

12 months

No ESA unless Hb dropped below 9 g/dL. 2/49 received ESA

N = 95: High Hb (46), Low Hb (49)

L: 11.7 vs 11.4

H: 11.6 vs 12.4

No significant difference in eGFR or sCr

Drueke 2006 [46]

94 centers 22 countries

Epoetin β to raise Hb to a target of 13–15 g/dL. Median was 5000 U 1X/week

48 months

Hb targeted to >10.5 g/dL. ESA only if Hb dropped below 10.5 g/dL. 67% received ESA during the study. Median 2000 U 1X/week

N = 603: High Hb (301), Low Hb (302)

L: 11.6 vs 11.4

H: 11.6 vs 13.5

No significant difference in the last eGFR value before initiation of dialysis. Time to initiation of dialysis was shorter in the high Hb group at 18 months (P = 0.03).

Gouva 2004 [47]

Greece

Epoetin α (50 U/kg 1x/week) to raise Hb from 9–11.6 g/dL to a Hb target of 13 g/dL

Treatment time was a median of 22.5 months (range 16–24)

No ESA for a median of 12 months (range 7–19), then no ESA unless Hb dropped below 9 g/dL.

N = 88: High Hb(45), Low Hb(43)

L: 10.1 vs 10.3

H: 10.1 vs 12.9

No difference in sCr

Levin 2005 [48]

Canada

Epoetin α (2000 U 1X/week) to raise and maintain Hb at 12.0–14.0 g/dL

24 months

Low Hb (<11 g/dL), 16/74 received ESA

N = 172: High Hb(85) Low Hb(87)

L: 11.7 vs 11.4

H: 11.8 vs 12.8

No difference in creatinine clearance. Change in eGFR slower in the treatment group (not significant)

MacDougall 2007 [49]

United Kingdom

Epoetin α (1000 U 2X/week) to maintain Hb at 11.0 g/dl. Total was 190,000 U

3 years

No ESA until Hb dropped below 9 g/dL (55/132 received ESA; total 152,000 U

N = 197: High Hb(65), Low Hb(132)

L: 10.9 vs 10.5

H: 10.8 vs 11.0

No difference in time to dialysis, creatinine clearance, change in creatinine clearance or death.

Pfeffer 2009 [50]

623 sites in 24 countries

Darbepoetin alfa 0.75 mcg/kg (Q2W and switched to QM); to increase Hb from 10.4 to 12.5 g/dL.

48 months; median duration of 29 months

No ESA until Hb dropped below 9 g/dL, 46% received 1 or more doses of ESA

N = 4038. High Hb(2012), low Hb(2026)

L:10.4 vs 10.6

H: 10.5 vs 12.5

No difference in the renal composite endpoint

Ritz 2007 [51]

64 centers in 16 countries

Epoetin β (2000 U/week) to a target Hb of 13–15 g/dL.

15 months

Hb target of 10.5–11.5 g/dL. 13/82 patients received ESA

N = 172: High Hb(89), Low Hb(83)

L: 11.7 vs 12.1

H: 11.9 vs 13.5

No effect on the rate of decrease in creatinine clearance, change in eGFR or urine protein

Roger 2004 [52]

Australia and New Zealand

Epoetin α 1X/week to increase Hb from 10 to 13 g/dL

24 months

ESA if Hb below 9 g/dL, 8/78 received ESA

N = 155: High Hb(75), Low Hb(80)

L: 11.2 vs 11.0

H: 11.2 vs 12.2

No difference eGFR or creatinine clearance at 2 years

Rossert 2006 [53]

93 centers in 22 countries

Epoetin α (25–100 U/kg 1X/week) to a Hb target of 13–15 g/dL. Median dose was 4,514 IU/week

4 months Hb stabilization then 7.4 months maintenance (high Hb) or 8.3 months (low Hb)

Hb target of 11–12 g/day. 65/195 received at least 1 ESA dose. Ave dose 2,730 IU/week (333–7667)

N = 390: High Hb(195), Low Hb(195)

L: 11.5 vs 11.7

H: 11.6 vs 13.9

No significant differences in rates of decrease in eGFR

Singh 2006 [54]

130 sites in USA

Epoetin α 1x/week to achieve Hb target of 13.5 g/dL. Ave 11,215 U/week

Median duration 16 months; 661 patients (46.2%) completed 36 months

Target Hb of 11 g/dL (709/717 received ESA) Ave dose 6276 U/week

N = 1432: High Hb (715), Low Hb (717)

L: 10.1 vs 11.3

H: 10.1 vs 12.6

No difference in hospitalization for RRT

Villar 2011 [55]

15 centers in France

ESA to target a Hb of 13–14.9 g/dL. Mean weekly ESA dose 6028 ± 6729 IU

24 months

Target Hb of 11–12.9 g/dL. Mean dose 1558 ± 1314 UI/week

N = 89: High Hb (46), Low Hb (43)

L: 11.5 vs 11.9

H: 11.4 vs 13.2

No difference in proteinuria or decline in eGFR (2 years)