A Simple Method of Estimating Progression of Chronic Renal Failure

Mitch, William E.; Walser, Mackenzie; Buffington, Gary A.; Lemann, Jacob

doi:10.1016/s0140-6736(76)91974-7

Cited by 440 publications

(195 citation statements)

References 4 publications

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“…In previous studies in smaller numbers of participants, a linear rate of decline has been reported (23)(24)(25)(26). In this large cohort, we found that as renal function declined, the rate of decline of renal function accelerated.…”

Section: Discussionsupporting

confidence: 72%

A Comparison of Iothalamate-GFR and Serum Creatinine-Based Outcomes

Lewis¹,

Greene²,

Appel³

et al. 2004

Journal of the American Society of Nephrology

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Abstract. In renal clinical trials, both slope-based and timeto-event renal outcomes have been used. These outcomes are typically based on estimates of GFR obtained using creatinine or iothalamate GFR (iGFR). The African American Study of Kidney Disease and Hypertension (AASK) was a trial in 1094 African Americans with hypertensive nephrosclerosis, which examined the effects of two levels of BP control and three antihypertensive regimens. This study compared the effects of the AASK interventions on outcomes based on serum creatinine with corresponding outcomes based on iGFR using 9742 matched pairs of iGFR and serum creatinine measurements. The iGFR-based outcomes included (1) a time-to-event composite outcome including a 50% GFR decline, ESRD, or death; (2) a composite outcome including a 50% GFR decline or ESRD; (3) mean decline in GFR in the first 3 mo after randomization (acute slope); (4) mean decline in GFR starting 3 mo after randomization (chronic slope); and (5) mean decline in GFR from baseline (total slope). The corresponding creatininebased outcomes were (1) a composite of doubling of serum creatinine, ESRD, or death and (2) a composite of doubling of serum creatinine or ESRD and acute, chronic, and total slopes defined by the mean change in estimated GFR (eGFR), where eGFR was estimated from a regression equation for GFR depending primarily on serum creatinine and developed in AASK enrollees. Mean changes in iGFR and eGFR were also compared under extended models that allowed for the possibility that the rate of GFR decline may change over time during the chronic phase. an apparent acceleration in rate of decline of renal function over time was found. Subtle differences were observed between effects of the interventions on some of the creatinine and iGFR slope-based outcomes, but the main conclusions of the trial were similar for the serum creatinine and iothalamatebased measurements. This has important implications for the design of clinical trials with renal outcomes.Choosing appropriate outcomes is critical to the success of clinical trials. In renal clinical trials to date, both slope-based and time-to-event renal outcomes have been used (1-5). In the slope-based analysis, GFR is estimated at multiple time points for all participants and curves constructed from these points that reflect the change in renal function over time. In most cases, constant slopes over time are assumed, and mean slopes are compared between the study groups to evaluate the effects of interventions on the rate of GFR decline. In time-to-event analysis, an event such as halving of GFR or ESRD is measured, and the time from randomization to the occurrence of these events is compared between the study groups.Inulin clearance is arguably the gold standard for accurately measuring GFR (6). In large clinical trials, however, 125

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Section: Discussionsupporting

confidence: 72%

A Comparison of Iothalamate-GFR and Serum Creatinine-Based Outcomes

Lewis¹,

Greene²,

Appel³

et al. 2004

Journal of the American Society of Nephrology

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“…FSGS in adult patients remains refractory, or frequent relapses and progression to ESRD are experienced. The rate of GFR loss varies from patient to patient, even among patients with the same renal disease, but for a given patient, the rate is generally believed to be constant (5). Recently, however, it was suggested that the decline slope may accelerate late in the course of chronic kidney disease (CKD) (6).…”

mentioning

confidence: 99%

Pirfenidone Slows Renal Function Decline in Patients with Focal Segmental Glomerulosclerosis

Cho¹,

Smith²,

Branton³

et al. 2007

Clinical Journal of the American Society of Nephrology

188

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Background and Objectives: Pirfenidone is an orally available antifibrotic agent that has shown benefit in animal models of pulmonary and renal fibrosis and in clinical trials of pulmonary fibrosis, multiple sclerosis, and hepatic cirrhosis. Our objective was to determine whether pirfenidone slows the loss of renal function in focal segmental glomerulosclerosis.Design, Setting, Participants, & Measurements: An open-label trial was performed to evaluate the safety and efficacy of pirfenidone in patients with idiopathic and postadaptive focal segmental glomerulosclerosis. The monthly change in estimated GFR, expressed as ml/min per 1.73 m 2 , was compared between the baseline period and the treatment period. During both periods, patients received angiotensin antagonist therapy if tolerated. Twenty-one patients were enrolled, and 18 patients completed a median of 13 mo of pirfenidone treatment.Results: The monthly change in GFR improved from a median of ؊0.61 ml/min per 1.73 m 2 (interquartile range ؊1.31 to ؊0.41) during the baseline period to ؊0.45 ml/min per 1.73 m 2 (interquartile range ؊0.78 to ؊0.16) with pirfenidone therapy. This change represents a median of 25% improvement in the rate of decline (P < 0.01). Pirfenidone had no effect on BP or proteinuria. Adverse events attributed to therapy included dyspepsia, sedation, and photosensitive dermatitis.Conclusions: It is concluded that pirfenidone is an attractive candidate for placebo-controlled trials in patients with progressive chronic kidney disease.

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“…The study design involving the 2-4-month initial period of aggressive DBP control at 80 mm Hg or less followed by control of DBP at less than 90 mm Hg was associated with long-term improvement in renal function. (Hypertension 1989; 13:766-772) M itch et al 1 have proposed that renal disease progression, once established, has a predictable and irrevocable pattern of decay in individuals. They reported that the reciprocal of the serum creatinine (l/S Cr ) concentration declined linearly as creatinine concentration rose from a mean of 3.0 mg/dl to 14 mg/dl during a mean interval of 77 months in three patients with hypertensive renal disease.…”

Section: Control In Hypertensive Nephrosclerosismentioning

confidence: 99%

Long-term improvement in renal function after short-term strict blood pressure control in hypertensive nephrosclerosis.

et al. 1989

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Seventy-nine hypertensive nephrosclerosis patients i entered a prospective randomized singleblind study to 1) establish the pattern of decay of renal function in this population and the variability therein and 2) to determine if strict diastolic blood pressure (DBP) control (<80 mm Hg) is more effective than conventional levels (90-95 mm Hg) in conserving renal function. Because of unexpected significant improvement in renal function in patients from both groups, which changed the perspectives on the course of this disease as described herein, this report is being published before completion of the trial. The selection criteria were 1) serum creatinine concentration of 1.6-7.0 mg/dl, 2) glomerular filtration rate of less than 70 ml/min/1.73 m 2 , and 3) absence of diseases (other than hypertension) known to destroy renal function. Renal function was assessed by glomerular filtration rate ([ l2S I]iothalamate clearance) and serum creatinine concentration. Before randomization, DBP was aggressively treated to reduce it to less than 80 mm Hg. Twenty-two subjects (14 in the strict DBP control group and eight in the conventional DBP control group) have been enrolled in the study for 36 months. In contrast to results from previous studies in humans and rats, renal function improved in both patient groups. Thus, irrevocable progression of renal damage after onset of renal failure from high blood pressure does not necessarily occur, and in fact, long-term improvement of renal function resulted from the effects of the study itself. The study design involving the 2-4-month initial period of aggressive DBP control at 80 mm Hg or less followed by control of DBP at less than 90 mm Hg was associated with long-term improvement in renal function. (Hypertension 1989; 13:766-772)

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A Simple Method of Estimating Progression of Chronic Renal Failure

Cited by 440 publications

References 4 publications

A Comparison of Iothalamate-GFR and Serum Creatinine-Based Outcomes

A Comparison of Iothalamate-GFR and Serum Creatinine-Based Outcomes

Pirfenidone Slows Renal Function Decline in Patients with Focal Segmental Glomerulosclerosis

Long-term improvement in renal function after short-term strict blood pressure control in hypertensive nephrosclerosis.

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