Efficacy and safety of recombinant human erythropoietin (Hema-Plus®) for management of anemia in Thai patients on peritoneal dialysis

Table 1 Demographic and baseline characteristics of the patients (n = 30)

Characteristics
Sex—No. of patients (%)
Male	18.0	(60.0)
Female	12.0	(40.0)
Age (years)1	48.8	(13.6)
Weight (kg)1	55.9	(11.1)
TSAT (%)2	39.6	(23.0)
Ferritin (ng/mL)2	931.2	(592.7)
Hemoglobin (g/dL)1	7.4	(1.3)
Hematocrit (%)1	22.2	(4.0)
Reticulocyte count (%)1	1.1	(0.9)
eGFR (ml/min/1.73 m2	6.2	(3.3)
BUN (mg%)2	77.1	(34.2)
Creatinine (mg%)2	10.0	(4.5)
Albumin (g%)2	3.8	(0.6)
Vitamin B12 (pg/mL)2,4	922.3	(422.9)
Folic acid (ng/mL)2,4
RBC folate (n = 19)	8192.8	(4785.0)
Serum folate (n = 10)	102.2	(217.4)
C-reactive protein (mg/L)2	10.7	(29.5)

All data were presented as mean (standard deviation), unless otherwise stated.

¹Data from screening visit.

²Data from Week 0 prior to study drug initiation.

³Data were calculated using chronic kidney disease epidemiology collaboration formula[13].

⁴Data available in 29 patients. BUN: Blood urea nitrogen; eGFR: Estimated glomerular filtration rate; RBC: Red blood cell; TSAT: Transferrin saturation.

Table 2 Pair-wise comparison of hemoglobin changes between 2 consecutive visits (n = 30)

Comparison	Hb change1	P value	Significance criteria
Week 0 vs Week 2	0.7 (0.2)	0.0003	0.0250
Week 2 vs Week 4	1.3 (0.2)	< 0.0001	0.0167
Week 4 vs Week 8	1.3 (0.2)	< 0.0001	0.0125
Week 8 vs Week 12	0.6 (0.2)	0.0060	0.0500

¹Data were presented as mean (standard error). P values and significance criteria presented were those after the pair-wise comparisons based on Bonferroni-Holm step-down adjustment. SE: Standard error; Hb: Hemoglobin.

Table 3 Frequency of patients with factors potentially affecting erythropoiesis-stimulating agent response (n = 30)

Factors potentially affecting ESA response	n (%)
Thalassemia	1 (3.33)
Infection	11 (36.67)
Hemolysis	0
Blood loss	0
Hyperparathyroidism	1 (3.33)
Low blood folic acid	0
Iron deficiency	3 (10.00)

ESA: Erythropoiesis-stimulating agent.

Table 4 Comparisons of hemoglobin at each visit by infection status (n = 30)

Visit	Hemoglobin levels (g/dL), mean (SD)		P value
	Infection (n = 11)	Non-infection (n = 19)
Visit 2 (week 0; baseline)	6.41(1.48)	7.95 (0.75)	0.001a	0.001b
Visit 3 (week 2)	7.00 (1.51)	8.68 (1.33)	0.004a
Visit 4 (week 4)	8.56 (1.53)	9.75 (1.33)	0.034a
Visit 5 (week 8)	9.85 (1.40)	11.00 (1.36)	0.035a
Visit 6 (week 12)	10.04 (1.73)	11.80 (1.39)	0.005a

Data were presented as mean (standard deviation).

^aRepeated measure ANOVA comparing hemoglobin (Hb) level between patients with and without infection within each visit.

^bRepeated measure ANOVA testing the effect of infection on overall Hb level.

Table 5 Comparisons of kidney disease quality of life instrument–36 scores at baseline and week 12 (n = 30)

Parameter	Week 0		Week 12		∆		P value1
SF-12 scores
Physical health composite	36.8	(8.2)	41.5	(9.8)	4.8	(8.5)	0.004
Mental health composite	41.5	(9.6)	48.4	(8.4)	6.9	(10.7)	0.001
Burden of kidney disease	34.4	(28.4)	46.0	(31.3)	11.7	(25.0)	0.016
Symptoms/problems of kidney disease	65.6	(19.6)	79.4	(13.6)	13.8	(20.4)	0.001
Effects of kidney disease	63.0	(18.2)	76.3	(18.4)	13.3	(23.6)	0.004

Data were presented as mean (standard deviation).

¹Paired t-test. ∆: Differences in KDQOL–36 scores between week 0 and week 12; KDQOL: Kidney disease quality of life instrument; SF: Short form health survey.

Table 6 Adverse events (n = 37)

Adverse events	No. of patients (%)	No. of events
Total	18 (48.65)	39
Blood and lymphatic disorders
Bicytopenia1	1 (2.70)	1
Gastrointestinal disorders
Diarrhea	1 (2.70)	1
Nausea	1 (2.70)	1
Infections and infestations
Exit site infection/inflammation	6 (16.22)	6
Pneumonia1	2 (5.40)	2
Eosinophilic peritonitis	2 (5.40)	2
Injury, poisoning and procedural complications
Closed fractures of femur1	1 (2.70)	1
Accidental tear small bowel1	1 (2.70)	1
Investigations
Hyperkalemia	1 (2.70)	1
Hypokalemia	1 (2.70)	1
Hyperphosphatemia	1 (2.70)	1
Metabolism and nutrition disorders
Hypoglycemia	2 (5.40)	2
Musculoskeletal and connective tissue disorders
Acute arthritis	1 (2.70)	1
Nervous system disorders
Headache	1 (2.70)	1
Dizziness	1 (2.70)	1
Renal and urinary disorders
Volume overload1,2	1 (2.70)	1
Respiratory, thoracic and mediastinal disorders
Chest discomfort	1 (2.70)	1
Bronchospasm	1 (2.70)	1
Pleural effusion1	1 (2.70)	1
Skin and subcutaneous tissue disorders
Edema	4 (10.81)	4
Paleness	1 (2.70)	2
Cellulitis	1 (2.70)	1
Itching from dry skin	1 (2.70)	1
Surgical and medical procedures
Catheter malfunction/ malposition3	2 (5.40)	2
Vascular disorder
Hypertensive urgency1,4	2 (5.40)	2

¹Serious adverse event.

²Severe adverse event.

³Only one out of two events were serious adverse event.

⁴The causality was deemed as probable.