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Sickle cell nephropathy pathophysiology in sickle cell disease: Adapted fromOkafor 2013andNath 2015 RBC: red blood cells; FSGS: focal segmental glomerulosclerosis; ESRD: end‐stage renal disease
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Figure 1

Sickle cell nephropathy pathophysiology in sickle cell disease: Adapted fromOkafor 2013andNath 2015

RBC: red blood cells; FSGS: focal segmental glomerulosclerosis; ESRD: end‐stage renal disease

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Structure of the kidney. From: Wikispaces. Human Physiology. 12. Urology.https://humanphysiology2011.wikispaces.com/12.+Urology
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Figure 2

Structure of the kidney. From: Wikispaces. Human Physiology. 12. Urology.https://humanphysiology2011.wikispaces.com/12.+Urology

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Study flow diagram.
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Figure 3

Study flow diagram.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 4

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 5

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 Hydroxyurea vs placebo, Outcome 1 Slower progression or improvement in GFR (mL per min per 1·73 m²).
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Analysis 1.1

Comparison 1 Hydroxyurea vs placebo, Outcome 1 Slower progression or improvement in GFR (mL per min per 1·73 m²).

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Comparison 1 Hydroxyurea vs placebo, Outcome 2 Improvement in ability to concentrate urine (mOsm/kg).
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Analysis 1.2

Comparison 1 Hydroxyurea vs placebo, Outcome 2 Improvement in ability to concentrate urine (mOsm/kg).

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Comparison 1 Hydroxyurea vs placebo, Outcome 3 SAEs assessed with acute chest syndrome.
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Analysis 1.3

Comparison 1 Hydroxyurea vs placebo, Outcome 3 SAEs assessed with acute chest syndrome.

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Comparison 1 Hydroxyurea vs placebo, Outcome 4 SAEs assessed with painful crisis.
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Analysis 1.4

Comparison 1 Hydroxyurea vs placebo, Outcome 4 SAEs assessed with painful crisis.

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Comparison 1 Hydroxyurea vs placebo, Outcome 5 SAEs assessed with hospitalisations.
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Analysis 1.5

Comparison 1 Hydroxyurea vs placebo, Outcome 5 SAEs assessed with hospitalisations.

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Comparison 1 Hydroxyurea vs placebo, Outcome 6 SAEs assessed with stroke.
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Analysis 1.6

Comparison 1 Hydroxyurea vs placebo, Outcome 6 SAEs assessed with stroke.

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Comparison 1 Hydroxyurea vs placebo, Outcome 7 AEs assessed with neutropenia.
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Analysis 1.7

Comparison 1 Hydroxyurea vs placebo, Outcome 7 AEs assessed with neutropenia.

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Comparison 1 Hydroxyurea vs placebo, Outcome 8 AEs assessed with thrombocytopenia.
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Analysis 1.8

Comparison 1 Hydroxyurea vs placebo, Outcome 8 AEs assessed with thrombocytopenia.

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Comparison 1 Hydroxyurea vs placebo, Outcome 9 Number of participants transfused.
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Analysis 1.9

Comparison 1 Hydroxyurea vs placebo, Outcome 9 Number of participants transfused.

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Comparison 2 ACEI (captopril) vs placebo, Outcome 1 Slower progression or reduction in proteinuria (mg/day).
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Analysis 2.1

Comparison 2 ACEI (captopril) vs placebo, Outcome 1 Slower progression or reduction in proteinuria (mg/day).

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Comparison 2 ACEI (captopril) vs placebo, Outcome 2 Other drug‐related adverse events (dry cough).
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Analysis 2.2

Comparison 2 ACEI (captopril) vs placebo, Outcome 2 Other drug‐related adverse events (dry cough).

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Summary of findings for the main comparison. Hydroxyurea compared to placebo for preventing or reducing kidney complications in people with sickle cell disease

Hydroxyurea compared to placebo for preventing or reducing kidney complications in people with sickle cell disease

Patient or population: people with sickle cell disease
Setting: multiple centres
Intervention: hydroxyurea
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(99% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo

Risk with hydroxyurea

Slower progression or improvement in GFR mL per min per 1.73 m² (measured at 18 to 24 months)

The mean slower progression or improvement in GFR mL per min per 1.73 m² (measured at 18 to 24 months) was 146.64 (43.7)

MD 0.58 higher
(14.6 lower to 15.76 higher)

‐

142
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 2

Improvement in ability to concentrate urine mOsm/kg (measured at 18 to 24 months)

The mean improvement in ability to concentrate urine mOsm/kg (measured at 18 to 24 months) was 494.57 (110.07)

MD 42.23 higher
(12.14 higher to 72.32 higher)

‐

178
(1 RCT)

⊕⊕⊝⊝
LOW 2,3

SAEs assessed with acute chest syndrome

Study population

RR 0.39
(0.13 to 1.16)

193
(1 RCT)

⊕⊕⊝⊝
LOW 2, 3

186 per 1000

72 per 1000
(24 to 215)

SAEs assessed with painful crisis

Study population

RR 0.68
(0.45 to 1.02)

193
(1 RCT)

⊕⊕⊝⊝
LOW 2, 3

567 per 1000

386 per 1000
(255 to 578)

SAEs assessed with hospitalisations

Study population

RR 0.83
(0.68 to 1.01)

193
(1 RCT)

⊕⊕⊝⊝
LOW 2, 3

866 per 1000

719 per 1000
(589 to 875)

Mortality due to any cause

No deaths reported in either group

not estimable

193
(1 RCT)

⊕⊕⊝⊝
LOW 2, 4

Quality of life

Not reported

‐

‐

‐

‐

*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; GFR: glomerular filtration rate; MD: mean difference; RCT: randomised controlled trial; RR: risk ratio; SAEs: serious adverse events.

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 We downgraded the quality of evidence by one due to unclear risk of attrition bias.
2 We downgraded the quality of evidence by one due to indirectness as the results apply only to small children aged 8 to 19 months.
3 We downgraded the quality of evidence by one due to imprecision as confidence intervals are wide indicating clinically significant harm or benefit.
4 We downgraded the quality of evidence by one due to imprecision; rare event no deaths occurred.

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Summary of findings for the main comparison. Hydroxyurea compared to placebo for preventing or reducing kidney complications in people with sickle cell disease
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Summary of findings 2. ACEI compared to placebo in preventing or reducing kidney complications in people with sickle cell disease

ACEI compared to placebo in preventing or reducing kidney complications in people with sickle cell disease

Patient or population: people with sickle cell disease
Setting: hospital outpatient
Intervention: ACEI
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo

Risk with ACEI

Slower progression or reduction in proteinuria (mg/day 6 months follow‐up)

The mean slower progression or reduction in proteinuria (mg/day 6 months follow‐up) was 76 (45)

MD 49.00 lower
(124.10 lower to 26.10 higher)

‐

22
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1, 2 ,3

Improvement in ability to concentrate urine mOsm/kg

Not reported

‐

‐

‐

SAEs assessed with acute chest syndrome

Not reported

‐

‐

‐

SAEs assessed with painful crisis

Not reported

‐

‐

‐

SAEs assessed with hospitalisations

Not reported

‐

‐

‐

Mortality due to any cause

Not reported

‐

‐

‐

Quality of life

Not reported

‐

‐

‐

ACEI: angiotensin converting enzyme inhibitor; CI: confidence interval; MD: mean difference; SAEs: serious adverse events

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 We downgraded the quality of evidence by two due to unclear or high risk of bias in all domains.
2 We downgraded the quality of evidence by one due to indirectness because a small sample population of adults with normal blood pressure and microalbuminuria.
3 We downgraded the quality of evidence by one due to imprecision as very wide CIs including clinically significant harm or benefit.

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Summary of findings 2. ACEI compared to placebo in preventing or reducing kidney complications in people with sickle cell disease
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Table 1. Unadjusted HRs for SAEs and AEs reported in BABY HUG 2011

Unadjusted HRs reported in BABY HUG 2011

Outcome

HR

95% CI

Acute chest syndrome

0.36

0.15 to 0.87

Painful crisis

0.54

0.36 to 0.83

Hospitalisations

0.73

0.53 to 1.00

Neutropenia

3.0

1.7 to 5.1

Thrombocytopenia

1.6

0.6 to 4.1

Transfusions

0.55

0.32 to 0.96

CI: confidence interval
HR: hazard ratio

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Table 1. Unadjusted HRs for SAEs and AEs reported in BABY HUG 2011
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Comparison 1. Hydroxyurea vs placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Slower progression or improvement in GFR (mL per min per 1·73 m²) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 at 18 to 24 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 Improvement in ability to concentrate urine (mOsm/kg) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

2.1 at 18 to 24 months

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

3 SAEs assessed with acute chest syndrome Show forest plot

1

Risk Ratio (M‐H, Random, 99% CI)

Totals not selected

4 SAEs assessed with painful crisis Show forest plot

1

Risk Ratio (M‐H, Random, 99% CI)

Totals not selected

5 SAEs assessed with hospitalisations Show forest plot

1

Risk Ratio (M‐H, Random, 99% CI)

Totals not selected

6 SAEs assessed with stroke Show forest plot

1

Peto Odds Ratio (Peto, Fixed, 99% CI)

Totals not selected

7 AEs assessed with neutropenia Show forest plot

1

Risk Ratio (M‐H, Random, 99% CI)

Totals not selected

8 AEs assessed with thrombocytopenia Show forest plot

1

Risk Ratio (M‐H, Random, 99% CI)

Totals not selected

9 Number of participants transfused Show forest plot

1

Risk Ratio (IV, Random, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Hydroxyurea vs placebo
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Comparison 2. ACEI (captopril) vs placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Slower progression or reduction in proteinuria (mg/day) Show forest plot

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

1.1 at 6 months follow‐up

1

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

2 Other drug‐related adverse events (dry cough) Show forest plot

1

Risk Ratio (M‐H, Random, 99% CI)

Totals not selected
Figuras y tablas -
Comparison 2. ACEI (captopril) vs placebo
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