Age- and height-adjusted total kidney volume growth rate in autosomal dominant polycystic kidney diseases

Higashihara, Eiji; Yamamoto, Keiji; Kaname, Shinya; Okegawa, Takatsugu; Tanbo, Mitsuhiro; Yamaguchi, Tsuyoshi; Shigemori, Kaori; Miyazaki, Isao; Yokoyama, Kenichi; Nutahara, Kikuo

doi:10.1007/s10157-018-1617-8

Cited by 11 publications

(20 citation statements)

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“…Subgrouping using K = 150 does not decrease the role of predicting the rate of estimated glomerular filtration rate decline and enriching the design in clinical trials, because a small change in eHTKV-α does not affect subgrouping limits seriously. 11 , 12 , 19 , 20 However, because eHTKV-α (K = 150) changed significantly from baseline as age advanced in placebo-assigned and standard-of-care subjects ( Table 3 ), it will affect estimations of change in the HTKV growth rate (eHTKV-α) from baseline to postbaseline.…”

Section: Discussionmentioning

confidence: 99%

“…It was reported that eHTKV-α (K = 150) was higher in subjects with PKD1 mutation than in subjects with PKD2 mutation. 11 An association of a higher growth rate of HtTKV with higher risk of disease progression can be identified using eHTKV-α.…”

Section: Discussionmentioning

confidence: 99%

“…The TKV growth rate estimated by using 1 TKV observation and age is more stable than the TKV growth rate estimated by using 2 TKV observations, because the TKV measurement error is spread to 20 or more years in the former case but the error is spread to only 1 or 2 years in the latter case. 11 In the prospective, placebo-controlled TEMPO 3:4 trial, a mixed-model repeated-measures analysis (MMRM) was applied to reveal a treatment benefit in reducing the TKV growth rate. 8 This study aimed to estimate TKV growth rate using only 1 TKV observation and the age when the TKV was observed.…”

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confidence: 99%

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Estimation of Changes in Kidney Volume Growth Rate in ADPKD

Higashihara

Fukuhara

Lee

et al. 2020

Kidney International Reports

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Introduction: In the Mayo Imaging Classification (MIC) for autosomal dominant polycystic kidney disease (ADPKD), the height-adjusted total kidney volume (HtTKV) growth rate is estimated for classification. Estimated HtTKV slope, termed as eHTKV-a, is calculated by the equation [HtTKV at age t] ¼ K(1þa/100) (t-A) , where K ¼ 150 and A ¼ 0 are used in MIC. If eHTKV-a is nearly stable during a standard-ofcare period, the change in eHTKV-a from baseline can be used for estimation of the treatment effect on the HtTKV slope. Methods: The constancy of eHTKV-a (A ¼ 0 and K ¼ 150) was evaluated using 453 placebo-assigned subjects in the Tolvaptan Efficacy and Safety in Management of ADPKD and Its Outcomes (TEMPO) 3:4 trial. A and K were sought out respectively by a converged pattern of regression lines of log10(HtTKV) plotted against age for subgroups divided according to MIC, and by change in eHTKV-a from baseline. A total of 239 standard-of-care patients from the Kyorin University Cohort (KUC) served as validation. Changes in eHTKV-a from baseline were evaluated in 809 tolvaptan-treated subjects in TEMPO 3:4. Results: In placebo-assigned subjects, eHTKV-a (A ¼ 0 and K ¼ 150) changed significantly from baseline at the third year. As regression lines of placebo-assigned subgroups converged around age 0, A was set as 0, which was confirmed by KUC. K ¼ 130 was selected because of minimal change in eHTKV-a from baseline. The KUC validated the constancy of eHTKV-a (A ¼ 0 and K ¼ 130) but not that of eHTKV-a (A¼0 and K¼150). In tolvaptan-treated subjects, eHTKV-a remained significantly lower than baseline for 3 years. Conclusions: eHTKV-a (A ¼ 0 and K ¼ 130) was nearly stable from baseline through follow-up in standardof-care adults. Treatment effects on the HtTKV slope can be estimated by changes in eHTKV-a from baseline.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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Estimation of Changes in Kidney Volume Growth Rate in ADPKD

Higashihara

Fukuhara

Lee

et al. 2020

Kidney International Reports

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“…Limited data suggest the possibility of faster renal progression in Asian patients with chronic kidney disease (CKD) compared with the Western population 9–11. However, previous studies on Asian ADPKD populations were conducted in a single country, which under-represented the whole Asian ADPKD population 12–27. Moreover, to date, studies that identified patients with ADPKD with rapid progression were mostly conducted in the Western population 5 28–30.…”

Section: Introductionmentioning

confidence: 99%

RAPID-ADPKD (Retrospective epidemiological study of Asia-Pacific patients with rapId Disease progression of Autosomal Dominant Polycystic Kidney Disease): study protocol for a multinational, retrospective cohort study

Ryu

Park

et al. 2020

BMJ Open

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IntroductionPatients with autosomal dominant polycystic kidney disease (ADPKD) reach end-stage renal disease in their fifth decade on average. For effective treatment and early intervention, identifying subgroups with rapid disease progression is important in ADPKD. However, there are no epidemiological data on the clinical manifestations and disease progression of patients with ADPKD from the Asia-Pacific region.Methods and analysisThe RAPID-ADPKD (Retrospective epidemiological study ofAsia-Pacific patients with rapIdDisease progression ofAutosomalDominantPolycysticKidneyDisease) study is a multinational, retrospective, observational cohort study of patients with ADPKD in the Asia-Pacific region (Australia, China, Hong Kong, South Korea, Taipei and Turkey). This study was designed to identify the clinical characteristics of patients with ADPKD with rapid disease progression. Adult patients with ADPKD diagnosed according to the unified ultrasound criteria and with an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2at baseline will be included. The cohort will include patients with ≥2 records of eGFR and at least 24 months of follow-up data. Demographic information, clinical characteristics, comorbidities, medications, eGFR, radiological findings that allow calculation of height-adjusted total kidney volume, ADPKD-related complications and the Predicting Renal Outcomes in autosomal dominant Polycystic Kidney Disease (PRO-PKD) score will be collected. Rapid progression will be defined based on the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) guideline. All other patients without any of these criteria will be classified to be of slow progression. Clinical characteristics will be compared between patients with rapid progression and those with slow progression. The incidence of complications and the effects of race and water intake on renal progression will also be analysed. The planned sample size of the cohort is 1000 patients, and data from 600 patients have been collected as of 30 May 2019.Ethics and disseminationThis study was approved or is in the process of approval by the institutional review boards at each participating centre. The results will be presented in conferences and published in a journal, presenting data on the clinical characteristics, risk factors for disease progression and patterns of complications of ADPKD in Asian populations.

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Hemorrhagic Cysts and Other MR Biomarkers for Predicting Renal Dysfunction Progression in Autosomal Dominant Polycystic Kidney Disease

Riyahi

Dev

Blumenfeld

et al. 2020

Magnetic Resonance Imaging

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BackgroundScreening for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) is necessary for assigning and monitoring therapies. Height‐adjusted total kidney volume (ht‐TKV) is an accepted biomarker for clinical prognostication, but represents only a small fraction of information on abdominal MRI.PurposeTo investigate the utility of other MR features of ADPKD to predict progression.Study TypeSingle‐center retrospective.PopulationLongitudinal data from 186 ADPKD subjects with baseline serum creatinine, PKD gene testing, abdominal MRI measurements, and ≥2 follow‐up serum creatinine were reviewed.Field Strength/Sequence1.5T, T2‐weighted single‐shot fast spin echo, T1‐weighted 3D spoiled gradient echo (liver accelerated volume acquisition) and 2D cine velocity encoded gradient echo (phase contrast MRA).AssessmentHt‐TKV, renal blood flow (RBF), number and fraction of renal and hepatic cysts, bright T1 hemorrhagic renal cysts, and liver and spleen volumes were independently assessed by three observers blinded to estimated glomerular filtration rate (eGFR) data.Statistical TestsLinear mixed‐effect models were applied to predict eGFR over time using MRI features at baseline adjusted for confounders. Validation was performed in 158 patients who had follow‐up MRI using receiver operator characteristic, sensitivity, and specificity.ResultsHemorrhagic cysts, fraction of renal and hepatic cysts, height‐adjusted liver and spleen volumes were significant independent predictors of future eGFR (final prediction model R2 = 0.88 P < 0.05). The number of hemorrhagic cysts significantly improved the prediction compared to ht‐TKV in predicting future eGFR (area under the curve [AUC] = 0.94, 95% confidence interval [CI]: 0.9–0.94 vs. R2 = 0.9, 95% CI: 0.85–0.9, P = 0.045). For baseline eGFR ≥60 ml/min/1.73m2, sensitivity for predicting eGFR<45 ml/min/1.73m2 by ht‐TKV alone was 29%. Sensitivity increased to 72% with all MRI variables in the model (P < 0.05 = 0.019), whereas specificity was unchanged, 100% vs. 99%.Data ConclusionCombining multiple MR features including hemorrhagic renal cysts, renal cyst fraction, liver and spleen volume, hepatic cyst fraction, and renal blood flow enhanced sensitivity for predicting eGFR decline in ADPKD compared to the standard model including only ht‐TKV.Level of Evidence 2Technical Efficacy Stage 2J. MAGN. RESON. IMAGING 2021;53:564–576.

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Age- and height-adjusted total kidney volume growth rate in autosomal dominant polycystic kidney diseases

Abstract: MIC is a good renal prediction model applicable to Japanese patients also. AHTKV-α can be a more sensitive and reliable indicator in TKV growth rate than HtTKV slope.

Cited by 11 publications

References 24 publications

Estimation of Changes in Kidney Volume Growth Rate in ADPKD

Estimation of Changes in Kidney Volume Growth Rate in ADPKD

RAPID-ADPKD (Retrospective epidemiological study of Asia-Pacific patients with rapId Disease progression of Autosomal Dominant Polycystic Kidney Disease): study protocol for a multinational, retrospective cohort study

Hemorrhagic Cysts and Other MR Biomarkers for Predicting Renal Dysfunction Progression in Autosomal Dominant Polycystic Kidney Disease

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