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. 2019 Oct 22;2019(10):CD005015. doi: 10.1002/14651858.CD005015.pub4

Starke 2012.

Methods

  • Study design: open‐label, active comparator, parallel RCT

  • Duration of study: June 2007 to January 2009

  • Duration of follow‐up: 1 year
Participants

  • Country: Switzerland

  • Setting: single centre

  • Inclusion criteria: kidney transplant recipients (age 18 to 65 years) between 3 months and 8 years post transplant (live donor); venous serum bicarbonate < 24 mmol/L; eGFR > 30 mL/min/1.73 m2

  • Number: treatment group (19); control group (11)

  • Mean age ± SD (years): treatment group (48 ± 12); control group (48 ± 8)

  • Sex (M/F): treatment group (15/4); control group (11/0)

  • Exclusion criteria: acute rejection episodes; severe physical limitation; psychiatric disorder; malignancy; catabolic state due to systemic illness; acute systemic infection; pregnancy
Interventions Treatment group

  • Potassium citrate: dosed to achieve bicarbonate > 24 mmol/L


Control group

  • Potassium chloride: dosed to achieve bicarbonate > 24 mmol/L


Co‐interventions

  • Not reported
Outcomes

  • Change in serum calcium, phosphate, iPTH, alkaline phosphatase, vitamin D and biomarkers of bone turnover

  • Change in BMD at lumbar spine, total hip, femoral neck, and non‐dominant forearm (total and distal radius)
Notes

  • Funding source: Scientific grants from the Swiss National Science Foundation (3200B0‐112299) and the Hermann Klaus Foundation (Zurich, Switzerland). All study medication was provided by Vifor (Fribourg, Switzerland)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Selective reporting (reporting bias) High risk Patient important outcomes not captured or reported systematically
Other bias High risk Imbalances in gender and duration of transplantation between treatment groups at baseline