Prednisolone treatment in acute interstitial nephritis (PRAISE) – protocol for the randomized controlled trial

BMC Nephrology

Table 1 Overview of the study from inclusion to week 52

		Day 0^a	Day 2	Day 4	Week 1	Week 2	Week 4	Week 8	Week 12	Week 26	Week 52
Treatment	A	No treatment
Treatment	B	Oral prednisolone tapered over 8 weeks
Medical history		+
Biochemistry A		+	+	+	+	+	+	+	+	+	+
Biochemistry B		+							+	+	+
Biochemistry C		+			+		+		+		+
Study medication (group B)		+			+	+	+	+
Blood pressure, HR		+	+	+	+	+	+	+	+	+	+
Clinical examination		+			+	+	+	+	+	+	+
24 h urine		+					+		+		+
Spot urine A		+	+	+	+	+	+	+	+	+	+
Spot urine B		+			+		+		+		+
Questionnaire (SF36)		+					+		+		+

Biochemistry A: P-sodium, p-potassium, p-total calcium, p-ionized calcium, p-phosphate, p-creatinine, eGFR, p-urea, p-glucose, WBC, p-c-reactive protein (CRP), b-sedimentation rate, p-PTH
Biochemistry B: Hemoglobin A1C. p-TSH, p-25-Hydroxy-Vitamine D2 + D3
Biochemistry C: TGF-β1, BMP-7
Study medication: Dose and adverse effects
Clinical examination: Body weight and physical examination
24-h urine collection: Urinary volume and urinary sodium, creatinine, and albumin excretion
Spot urine A: Urine-dip stick (hemoglobin, protein, leucocytes, glucose, nitrite), urinary albumin and creatinine concentrations and urinary albumin/creatinine ratio
Spot urine B: Urinary concentration and ratios in relation to urinary creatinine of TGF-β1, BMP-7, A1M, B2M, MCP-1, NGAL, NAG, IL-18, TIMP-2, KIM-1, IGFBP7 and CD163-
Questionnaire: SF36 is filled in by the patient
^aBefore start of study medication

ISSN: 1471-2369