Tubular Secretion of Creatinine in Autosomal Dominant Polycystic Kidney Disease: Consequences for Cross-sectional and Longitudinal Performance of Kidney Function Estimating Equations

Spithoven, Edwin M.; Meijer, Esther; Boertien, Wendy E.; Sinkeler, Steef J.; Tent, Hilde; Jong, Paul E. de; Navis, Gerjan; Gansevoort, Ron T.

doi:10.1053/j.ajkd.2013.03.030

Cited by 21 publications

(18 citation statements)

References 27 publications

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“…However, serial measurement of kidney function in 300 patients with ADPKD in 4 different centers is not feasible, and it recently has been shown that measured GFR and eGFR in ADPKD are highly correlated. 58 Finally, in this study, total kidney volume will be measured using MRI, a method that is well validated. 4,14 …”

Section: Discussionmentioning

confidence: 99%

Rationale and Design of the DIPAK 1 Study: A Randomized Controlled Clinical Trial Assessing the Efficacy of Lanreotide to Halt Disease Progression in Autosomal Dominant Polycystic Kidney Disease

Meijer

Drenth

D’Agnolo

et al. 2014

American Journal of Kidney Diseases

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Background There are limited therapeutic options to slow the progression of autosomal dominant polycystic kidney disease (ADPKD). Recent clinical studies indicate that somatostatin analogues are promising for treating polycystic liver disease and potentially also for the kidney phenotype. We report on the design of the DIPAK 1 (Developing Interventions to Halt Progression of ADPKD 1) Study, which will examine the efficacy of the somatostatin analogue lanreotide on preservation of kidney function in ADPKD. Study Design The DIPAK 1 Study is an investigator-driven, randomized, multicenter, controlled, clinical trial. Setting & Participants We plan to enroll 300 individuals with ADPKD and estimated glomerular filtration rate (eGFR) of 30-60 mL/min/1.73 m2 who are aged 18-60 years. Intervention Patients will be randomly assigned (1:1) to standard care or lanreotide, 120 mg, subcutaneously every 28 days for 120 weeks, in addition to standard care. Outcomes Main study outcome is the slope through serial eGFR measurements starting at week 12 until end of treatment for lanreotide versus standard care. Secondary outcome parameters include change in eGFR from pretreatment versus 12 weeks after treatment cessation, change in kidney volume, change in liver volume, and change in quality of life. Measurements Blood and urine will be collected and questionnaires will be filled in following a fixed scheme. Magnetic resonance imaging will be performed for assessment of kidney and liver volume. Results Assuming an average change in eGFR of 5.2 ± 4.3 (SD) mL/min/1.73 m2 per year in untreated patients, 150 patients are needed in each group to detect a 30% reduction in the rate of kidney function loss between treatment groups with 80% power, 2-sided α = 0.05, and 20% protocol violators and/or dropouts. Limitations The design is an open randomized controlled trial and measurement of our primary end point does not begin at randomization. Conclusions The DIPAK 1 Study will show whether subcutaneous administration of lanreotide every 4 weeks attenuates disease progression in patients with ADPKD.

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Section: Discussionmentioning

confidence: 99%

Rationale and Design of the DIPAK 1 Study: A Randomized Controlled Clinical Trial Assessing the Efficacy of Lanreotide to Halt Disease Progression in Autosomal Dominant Polycystic Kidney Disease

Meijer

Drenth

D’Agnolo

et al. 2014

American Journal of Kidney Diseases

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“…In ADPKD patients at high measured GFR (>105 ml/min/1.73m 2 ), tubular secretion of creatinine has been shown to be significantly greater than in healthy controls with the same renal function, thus contributing to a lower plasma creatinine level at those early stages of the disease[16]. Nowadays CKD-EPI equation has been shown to be the most precise equation to estimate GFR especially for those with eGFR values >60ml/min/1.73m2[17].…”

Section: Discussionmentioning

confidence: 99%

Cystatin C estimated glomerular filtration rate to assess renal function in early stages of autosomal dominant polycystic kidney disease

et al. 2017

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Background/AimsHeight-adjusted total kidney volume (htTKV) is the best marker of disease progression in early autosomal dominant polycystic kidney disease (ADPKD) when renal function still remains normal. The usefulness of cystatin-C as a biomarker to assess renal function according to renal volume has not been studied in ADPKD patients.MethodsObservational and cross-sectional study of 62 ADPKD patients. htTKV, creatinine and cystatin-C estimated glomerular filtration rate (eGFR) were determined. Correlations between htTKV and eGFR were studied. A control group was used to determine the association between renal function differences and htTKV.ResultshtTKV significantly correlated with cystatin-C-eGFR (r = -0.384, p = 0.002) but not with creatinine-eGFR (r = -0.225, p = 0.078). With htTKV stratified into tertiles, a significant difference of cystatin-C-eGFR but not in creatinine-eGFR was detected in the third tertile when compared with the first tertile group (110.0±22.2 vs 121.3±7.2; p = 0.023 and 101.8±17.2 vs 106.9±15.1; p = 0.327 respectively). When cystatin-C-eGFR of the controls was used as the reference, htTKV above 605 ml/m identified with a 75% sensitivity and 84.9% specificity those patients with a significant worse kidney function. However, this cut-off value could not be identified using creatinine-eGFR.ConclusionsCystatin-C-eGFR but not creatinine-eGFR correlated with htTKV in ADPKD patients in early stages of the disease. Differences in cystatin-C-eGFR but not in creatinine-eGFR have been identified through htTKV tertiles. A htTKV above 605 ml/m is associated with a worse renal function only if cystatin-C-eGFR is used. Cystatin-C-eGFR should be studied in prospective studies of early stages of ADPKD to determine its usefulness as an early marker of disease progression.

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“…Here we compare the performance of measured (mGFR) and eGFR in the Consortium for Renal Imaging Studies of PKD (CRISP) 5–7 , a prospective study of 241 patients, 15–45 year-old, with an initial creatinine clearance >70 mL/min, and measurements of height adjusted total kidney volume (HtTKV), mGFR by the iothalamate clearance 5 and serum creatinine yearly during four years and biennially thereafter 8 . To adjust for calibration bias, serum samples were exchanged between the four study sites and the Cleveland Clinic Laboratory and calibration equations were derived for each site.…”

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“…Four studies have measured the bias, precision and accuracy of eGFR compared to mGFR in ADPKD 4,8,10 (Supplemental Table 3). In general the bias of eGFR is greater and the accuracy less when the mGFR values are high.…”

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Performance of the CKD-EPI Equation to Estimate GFR in a Longitudinal Study of Autosomal Dominant Polycystic Kidney Disease

Shen

Landsittel

Irazabal

et al. 2017

American Journal of Kidney Diseases

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Tubular Secretion of Creatinine in Autosomal Dominant Polycystic Kidney Disease: Consequences for Cross-sectional and Longitudinal Performance of Kidney Function Estimating Equations

Cited by 21 publications

References 27 publications

Rationale and Design of the DIPAK 1 Study: A Randomized Controlled Clinical Trial Assessing the Efficacy of Lanreotide to Halt Disease Progression in Autosomal Dominant Polycystic Kidney Disease

Rationale and Design of the DIPAK 1 Study: A Randomized Controlled Clinical Trial Assessing the Efficacy of Lanreotide to Halt Disease Progression in Autosomal Dominant Polycystic Kidney Disease

Cystatin C estimated glomerular filtration rate to assess renal function in early stages of autosomal dominant polycystic kidney disease

Performance of the CKD-EPI Equation to Estimate GFR in a Longitudinal Study of Autosomal Dominant Polycystic Kidney Disease

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